Indications and Important Safety Information

ADATO^® SIL-OL 5000

Indications

ADATO^® SIL-OL 5000 is indicated for use as a prolonged retinal tamponade in selected cases of complicated retinal detachments where other interventions are not appropriate for patient management. Complicated retinal detachments or recurrent retinal detachments occur most commonly in eyes with proliferative vitreoretinopathy (PVR), proliferative diabetic retinopathy (PDR), cytomegalovirus (CMV) retinitis, giant tears, and following perforating injuries. ADATO^® SIL- OL 5000 is also indicated for primary use in detachments due to Acquired Immune Deficiency Syndrome (AIDS) related CMV retinitis and other viral infections.

Contraindications

As silicone oil can chemically interact and opacify silicone elastomers, the use of ADATO^® SIL-OL 5000 is contraindicated in pseudophakic patients with silicone intraocular lenses (IOLs).

Warnings

Oil-induced pupillary block and angle closure can occur in aphakic eyes if a six o’clock iridectomy is not performed.
In rare instances, silicone oil could migrate out of the eye and form lesions in the conjunctiva or eyelid. The use of CO2 laser should be avoided in the presence of such silicone oil related skin lesions, due to potential ignition.

Precautions

• ADATO^® SIL-OL 5000 is supplied in a sterile syringe intended for single use only and contains no preservative.
• Do not resterilize.
• Discard unused portions of ADATO^® SIL-OL 5000.
• Do not mix oil with any other substances prior to injection.
• Product should be discarded following expiration date.
• An underfill may result in an ineffective inferior tamponade and an overfill may result in corneal abnormalities and elevated IOP.
• The use of ADATO^® SIL-OL 5000 as a long-term tamponade has not been studied and must be determined by the treating physician. ADATO^® SIL-OL 5000 should be removed when, in the judgement of the physician, the retinal attachment would not be compromised.
• The scleral incisions should be completely sealed to minimize the potential for postoperative extravasation of the oil into the sub-conjunctival space and eyelids.

Adverse Events

Adverse events occurring in the highest percentage of patients include cataract, anterior chamber oil migration, keratopathy, and glaucoma. Other less commonly occurring adverse events in greater than 2% of patients include redetachment, optic nerve atrophy, rubeosis iridis, temporary IOP increase, macular pucker, vitreous hemorrhage, phthisis, traction detachment, and angle block. Complications occurring at rates of less than 2% include subretinal strands, retinal rupture, endophthalmitis, subretinal silicone oil, choroidal detachment, aniridia, PVR reproliferation, cystoid macular edema, and enucleation.

Please see ADATO^® SIL-OL 5000 package insert for full prescribing and usage information.

CAUTION: Federal (USA) law restricts this device to the sale by or on the order of a physician.

Akreos^® Intraocular Lens

Indications

Akreos^® posterior chamber intraocular lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by phacoemulsification. The lens is intended for placement in the capsular bag.

Contraindications

Implantation is not advisable when the IOL may aggravate an existing condition, interfere with the diagnosis or treatment of a pathology, or present a risk to the sight of the patient.  These conditions are uncontrolled glaucoma, rubeotic cataract, retinal detachment, atrophy of the iris, microphthalmia, developing chronic eye infections, endothelial corneal dystrophy, perioperative complications (such as vitreous loss, hemorrhage, etc), foreseeable post-operative complications.

Warnings

Physicians considering lens implantation under any of the following circumstances should weigh the potential risk/benefit ratio: Patients with recurrent severe anterior or posterior segment inflammation or uveitis; patients in whom the intraocular lens may affect the ability to observe, diagnose or treat posterior segment diseases; surgical difficulties at the time of cataract extraction, which may increase the potential for complications (e.g., persistent bleeding, significant iris damage, uncontrolled positive pressure or significant vitreous prolapse or loss); a compromised eye due to previous trauma or developmental defect in which appropriate support of the IOL is not possible; circumstances that would result in damage to the endothelium during implantation; suspected microbial infection; patients in whom neither the posterior capsule nor the zonules are intact enough to provide support for the IOL; children under the age of 2 years are not suitable candidates for intraocular lenses. Since the clinical study for the Akreos^® intraocular lens was conducted with the lens being implanted in the capsular bag, there is insufficient clinical data to demonstrate its safety and efficacy for placement in the ciliary sulcus.  YAG posterior capsulotomies should be delayed until at least 12 weeks after the implant surgery.  The posterior capsulotomy opening should be kept as small as possible.  There is an increased risk of lens dislocation and/or secondary surgical intervention with early or large capsulotomies.  Improper handling may cause damage to the haptic or optic portions of Akreos^® foldable lenses.  If lenses are not handled appropriately, optic tears may result.  Physicians should not attempt to implant lenses that have radial optic tears or separations at the optic/haptic interface.  Use of folding instruments other than those validated and recommended in the labeling might result in IOL damage (optic tears, haptic damage) that might require IOL explantation.  To avoid the creation of permanent forceps marks in the central optic zone, exercise care during handling and insertion of the lens.

Precautions

Do not resterilize these lenses.  Do not reuse the IOL.  Do not store the device in direct sunlight or at a temperature below freezing (<0°C).  Store at room temperature.  Avoid high temperatures (>45°C).  Do not implant the IOL if the outer pouch or vial is opened or damaged.  Do not reuse the IOL.  Do not soak or rinse lenses in solutions other than balanced salt solution or equivalent.  The IOL should be used in the shortest possible time after opening the vial.  Do not implant the IOL if the lens is not completely immersed in solution under any vial orientation.  Akreos^®  lenses can absorb substances that they contact (disinfectant, drug).  Do not place the lens in contact with surfaces where such contamination can occur.  If YAG laser posterior capsulotomy is performed, assure that the laser beam is focused slightly behind the posterior capsule.  

Adverse Events

The incidence of adverse events experienced during the clinical trial was comparable to or lower than the incidence reported in the historic control (“FDA grid”) population. As with any surgical procedure, risk is involved. The most frequently reported cumulative adverse event that occurred during the clinical trial of the Akreos® was cystoid macular edema, which occurred at a rate of 1.4%. Persistent adverse events included macular edema (0.3%) and iritis (0.3%), which comparable to or lower than the incidence reported in the historic control (“FDA grid”) population, as well as corneal edema (0.9%) and raised IOP requiring treatment (0.6%), which were higher than the incidence reported in the FDA grid.  

ATTENTION: Refer to the Directions for Use labeling for a complete listing of indications, warnings and precautions, clinical trial information, etc. 

CAUTION: Federal (USA) law restricts this device to the sale by or on the order of a physician.

Amvisc^® and Amvisc^® Plus Viscoelastics

Indications

Amvisc^® and Amvisc^® Plus Viscoelastics are indicated for use as a surgical aid in ophthalmic anterior and posterior segment procedures including:

• Extraction of a cataract
• Implantation of an intraocular lens (IOL)
• Corneal transplantation surgery
• Glaucoma Filtering Surgery
• Surgical procedures to reattach the retina

Because of its lubricating and viscoelastic properties, transparency, and ability to protect corneal endothelial cells, Amvisc and Amvisc Plus helps maintain anterior chamber depth and visibility, minimizes interaction between tissues, and acts as a tamponade and vitreous substitute during retinal reattachment surgery. Amvisc and Amvisc Plus also preserves tissue integrity and good visibility when used to fill the anterior and posterior segments of the eye following open sky procedures.

Precautions

Those precautions normally considered during anterior segment and retinal attachment procedures are recommended. There may be increased intraocular pressure following surgery caused by pre-existing glaucoma or by the surgery itself. For these reasons, the following precautions should be considered:

• Do not use if the sterile packaging barrier has been breached.
• An excess quantity of Amvisc and Amvisc Plus should not be used.
• Amvisc and Amvisc Plus should be removed from the anterior chamber at the end of surgery
• If the postoperative intraocular pressure increases above expected values, correcting therapy should be administered.
• Amvisc and Amvisc Plus is prepared from a biological source and the physician should be aware of the possible effects of using any biological material.
• Reuse of cannula should be avoided. Even after cleaning and rinsing, resterilized cannula could release particulate matter as Amvisc and Amvisc Plus is injected. It is recommended that a single-use disposable cannula be used when administering Amvisc and Amvisc Plus.
• There have been isolated reports of diffuse particulates or haziness appearing after injection of Amvisc and Amvisc Plus into the eye. While such reports are infrequent and seldom associated with any effects on ocular tissues, the physician should be aware of this occurrence. If observed, the particulate matter should be removed by irrigation and/or aspiration.
• Store at 2-8° C. Protect from freezing.

Adverse Events

Sodium hyaluronate is a natural component of the tissues of the body and is extremely well tolerated in human eyes. Transient postoperative inflammatory reactions were reported in clinical trials and oral and topical steroid preparations were administered. Amvisc and Amvisc Plus are tested in animals to determine that they are essentially noninflammatory. Since sodium hyaluronate molecules are noninflammatory, any phlogistic response is considered to be caused by the surgical procedures. The best index of the degree of phlogistic response is the postoperative clarity of the vitreous cavity. As outlined above, transient postoperative increase in intraocular pressure has been observed following the use of sodium hyaluronate in anterior segment surgery.

On rare occasions postoperative reactions, including inflammation, corneal edema, and corneal decompensation have been reported. The relationship to the use of Amvisc and Amvisc Plus has not been established.

ATTENTION: Refer to the Directions for Use labeling for a complete listing of indications, warnings and precautions, clinical trial information, etc.

CAUTION: Federal (USA) law restricts this device to the sale by or on the order of a physician.

OcuCoat^® Viscoelastic

Indications

OcuCoat^® viscoelastic is indicated for use as an ophthalmic surgical aid in anterior segment surgical procedures, including cataract extraction and intraocular lens implantation. OcuCoat maintains a deep chamber during anterior segment surgery and thereby allows for more efficient manipulation with less trauma to the corneal endothelium and other ocular tissues.

Precautions

For intraocular use only. Discard unused contents of OcuCoat syringe after each use. Do not resterilize.

Precautions are limited to those normally associated with the ophthalmic surgical procedure being performed. There may be transient increased intraocular pressure following surgery because of pre- existing glaucoma or due to the surgery itself. For these reasons, the following precautions should be considered:

• OcuCoat should be removed from the anterior chamber at the end of surgery
• If the post-operative intraocular pressure increases above expected values, appropriate therapy should be administered

Adverse Events

Clinical testing of OcuCoat showed it to be extremely well tolerated after injection into the human eye.

A transient rise in intraocular pressure postoperatively has been reported in some cases.

Rarely, postoperative inflammatory reactions (iritis, hypopyon), as well as incidents of corneal edema and corneal decompensation, have been reported with viscoelastic agents. Their relationship to OcuCoat has not been established.

ATTENTION: Refer to the Directions for Use labeling for a complete listing of indications, warnings and precautions, clinical trial information, etc.

CAUTION: Federal (USA) law restricts this device to the sale by or on the order of a physician.

Bi-Blade^® Vitrectomy Cutter

Indications

The Bi-Blade^® Vitrectomy Cutter is a pneumatically actuated device that supports aspiration and guillotine-style cutting functions to remove vitreous and/or other tissues from the eye during surgery. The Bi-Blade^® Vitrectomy Cutter and the Bi-Blade^® Vitrectomy Cutter Packs are intended for use in conjunction with the Stellaris Elite^® or Stellaris PC^® Vision Enhancement Systems, as specified.
The Bi-Blade^® Posterior Vitrectomy Cutter Packs are intended for use for vitrectomy during posterior segment surgery. The Combined Bi-Blade^® Vitrectomy Cutter Packs are intended for use for both vitrectomy during posterior segment surgery and for phacoemulsification of an opacified crystalline lens during anterior segment surgery.

Warnings

• Failure to follow priming instructions for the vitrectomy cutter and aspiration tubing may result in poor aspiration response and reduction in vitrectomy cutter’s effectiveness.
• This product should only be used under the guidance of a trained and registered physician.
• Do not re-sterilize and do not re-use.
• Only use the Bi-Blade^® Vitrectomy Cutter and Bi-Blade^® Vitrectomy Cutter Packs with the Stellaris Elite^® or Stellaris PC^® Vision Enhancement Systems, as specified. Use with non-Bausch + Lomb products may affect system performance and create hazards.
• Do not use the Bi-Blade^® Vitrectomy Cutter or any item in a Bi-Blade^® Vitrectomy Cutter Pack if received in an unsatisfactory manner.

This is not all you need to know. See the Bi-Blade^® instructions for use for detailed directions, proper use, and full risk and safety information.

CAUTION: Federal (U.S.) Law restricts these devices to sale, by or on the order of a physician.

ClearVisc™, StableVisc™ and TotalVisc™ OVDs

Indications

ClearVisc, StableVisc and TotalVisc OVDs are indicated for use as surgical aids in ophthalmic anterior segment procedures including: Extraction of a cataract; Implantation of an intraocular lens (IOL)

Contraindications

There are no contraindications to the use of ClearVisc, StableVisc and TotalVisc when used as a surgical aid in ophthalmic anterior segment procedures.

Precautions

Precautions normally considered during anterior segment procedures are recommended. Pre-existing glaucoma may place patients at risk for increases in intraocular pressure from the OVD during the early postoperative period.

Warnings

• Do not use if the sterile barrier has been breached. Sterility cannot be guaranteed, and the patient will be at increased risk for infection.
• Do not use the OVD in subjects with known allergies to any of its components. 
• An excess quantity of OVD should not be used. Excess OVD can cause increased intraocular pressure.
• The OVD should be removed from the anterior chamber at the end of surgery to prevent or minimize postoperative intraocular pressure increases (spikes). OVD remaining in the eye can cause increased intraocular pressure.
• If the postoperative intraocular pressure increases above expected values, corrective therapy should be administered. Increased intraocular pressure may lead to inflammation or vision loss.
• Do not re-use the cannula. Even after cleaning and rinsing, resterilized cannula could release particulate matter as the OVD is injected. It is recommended that a single-use disposable cannula be used when administering the OVD. Reuse may cause eye inflammation.
• If any particulate matter is observed, it should be removed by irrigation and/or aspiration. Particulate matter left in the eye may cause increased IOP or Light scattering /obstruction.
• Store at 2° to 8°C (36° to 46°F). Protect from freezing. The shelf life of ClearVisc, StableVisc and TotalVisc is not guaranteed if it is not properly stored.

Adverse Reactions

Sodium hyaluronate is a natural component of tissues within the body and is generally well tolerated in human eyes. Transient postoperative inflammatory reactions and increases in intraocular pressure have been reported. Inflammation may result from increased intraocular pressure caused by use of the OVD. Intraocular inflammation, i.e., toxic anterior segment syndrome (TASS), has been attributed to OVDs. Furthermore, vision loss may be possible as a result of increased intraocular pressure and inflammation.

ATTENTION: Refer to the Directions for Use labeling for a complete listing of indications, warnings and precautions, clinical trial information, etc.

CAUTION: Federal (USA) law restricts this device to the sale by or on the order of a physician.

Clearvisc™ OVD

Indications

ClearVisc is indicated for use as a surgical aid in ophthalmic anterior segment procedures including: Extraction of a cataract; Implantation of an intraocular lens (IOL)

Contraindictions

There are no contraindications to the use of ClearVisc when used as a surgical aid in ophthalmic anterior segment procedures. 

Precautions

Precautions normally considered during anterior segment procedures are recommended. Pre-existing glaucoma may place patients at risk for increases in intraocular pressure from the OVD during the early postoperative period.  

Warnings

• Do not use if the sterile barrier has been breached. Sterility cannot be guaranteed, and the patient will be at increased risk for infection. 
• An excess quantity of ClearVisc should not be used. Excess OVD can cause increased intraocular pressure. 
• ClearVisc should be removed from the anterior chamber at the end of surgery to prevent or minimize postoperative intraocular pressure increases (spikes). OVD remaining in the eye can cause increased intraocular pressure. 
• If the postoperative intraocular pressure increases above expected values, corrective therapy should be administered. Increased intraocular pressure may lead to inflammation or vision loss. 
• Do not re-use the cannula. Even after cleaning and rinsing, resterilized cannula could release particulate matter as ClearVisc is injected. It is recommended that a single-use disposable cannula be used when administering ClearVisc. Reuse may cause eye inflammation. 
• If any particulate matter is observed, it should be removed by irrigation and/or aspiration. Particulate matter left in the eye may cause increased IOP or Light scattering /obstruction. 
• Store at 2° to 8°C (36° to 46°F). Protect from freezing. The shelf life of ClearVisc is not guaranteed if it is not properly stored.

Adverse Reactions

Sodium hyaluronate is a natural component of tissues within the body and is generally well tolerated in human eyes. Transient postoperative inflammatory reactions and increases in intraocular pressure have been reported. Inflammation may result from increased intraocular pressure caused by use of the OVD. Intraocular inflammation, i.e., toxic anterior segment syndrome (TASS), has been attributed to OVDs. Furthermore, vision loss may be possible as a result of increased intraocular pressure and inflammation. 

Clinical Trial

A clinical study was performed with ClearVisc ophthalmic viscoelastic device (OVD) used as a surgical aid in patients undergoing ophthalmic anterior segment procedures.  The study was a prospective, multi-center, active control (VISCOAT OVD), two-armed, randomized, partially masked, comparative clinical trial.   A total of 372 subjects were enrolled at 16 investigational sites, and subjects were followed for 90 days postoperatively.  

The primary effectiveness endpoint of the pivotal clinical trial was the non-inferiority of the ClearVisc investigative device group when compared with the VISCOAT control device group in the mean percent corneal endothelial cell density (ECD) from baseline to the 90 day follow-up visit in the study eye.  The ClearVisc control group has a mean percent change of 8.4% loss in ECD from baseline to the 90 day follow-up visit, whereas the VISCOAT group had a mean percent change of 6.8% loss.  Non-inferiority was demonstrated statistically.  

The primary safety endpoint was the non-inferiority of the ClearVisc group when compared with the VISCOAT group in the proportion of subjects who experienced at least one intraocular pressure (IOP) measurement greater than or equal to 30 mmHg in the study eye at any follow-up visit.  The proportion of subjects with postoperative IOP ≥ 30 mmHg at any follow-up visit was 17% (31 / 184 subjects) for the ClearVisc group and 17% (38 / 187 subjects) for the control group.  Non-inferiority was met statistically.

There does not appear to be a clinically significant difference in the adverse events that occurred during the trial between the two groups.  For the main risks of increased IOP and intraocular inflammation, rates were 16.8% (31 / 184 subjects) and 6% (11 / 184 subjects) respectively in the ClearVisc group and 20.2% (38/188 subjects) and 3.7% (7 / 188 subjects) respectively in the VISCOAT group.

ATTENTION: Refer to the Directions for Use labeling for a complete listing of indications, warnings and precautions, clinical trial information, etc.

CAUTION: Federal (USA) law restricts this device to the sale by or on the order of a physician.

Crystalens^® posterior chamber accommodating IOL

Indications

Crystalens^® accommodating posterior chamber intraocular lens (IOL) is for use in adult patients to improve uncorrected near, intermediate and far (distance) vision after cataract removal.

Important Safety Information

Your eye doctor will advise you about the potential risks and benefits of cataract removal and IOL implantation.

Cataract surgery is one of the most common surgical procedures performed; however, as with all surgeries there are warnings, precautions, and risks that you should be aware of.

• Tell your eye doctor if you have been diagnosed with any eye disease. The safety and effectiveness of Crystalens has not been established in patients with preexisting eye conditions and complications during surgery, such as an increase in eye pressure (glaucoma) or complications of diabetes in the eye (diabetic retinopathy). The outcome of cataract surgery will depend on the health of your eye before surgery.
• Tell your eye doctor if you have had prior refractive surgery, such as LASIK. The safety and effectiveness of the Crystalens has not been studied in patients with prior refractive surgery.
• You will need to wear glasses if you have any of the following:
  • Nearsightedness or farsightedness after surgery: These conditions may result from errors in measurements before surgery, wrong lens power, or changes in the cornea in response to the surgery.
  • Uncorrected astigmatism after surgery: This condition may result from the same reasons as stated above.
  • If you must do prolonged reading or read small print, you are likely to need to wear reading glasses.
• Avoid any activity that could harm your eye while you are recovering from surgery. For example, avoid any activities where objects can come in contact with or put pressure on the eye, such as tennis or scuba diving.
• Unlike most other IOLs, the Crystalens AO IOL contains hinges. There are adverse events in which the lens moves into a displaced position when the hinges get stuck. These events are referred to as cases of “lens vault” or “vaulting” and typically cause blurry vision. These may come on suddenly or gradually. If you have only one good eye, and vaulting occurs suddenly, it can make driving or other similar situations hazardous. If this occurs, you should exercise caution. In any case, if you experience blurred vision you should contact your eye doctor promptly to determine the cause. When vaulting occurs, a second surgery is often required to restore the lens to its correct position; sometimes it is necessary to remove the lens.

Potential Risks

The complications and side effects experienced during the clinical study were similar to those experienced with other intraocular lenses and with routine cataract surgery. Cataract surgery is not completely risk-free. Complications may occur as a result of the removal of your cataract whether or not an intraocular lens is implanted.

Complications of cataract surgery range from minor, usually temporary side effects, to sight- threatening complications. Fortunately, significant sight-threatening complications are extremely rare and include, but are not limited to: infection, hemorrhage, and retinal detachment. People with existing medical conditions such as diabetes and chronic eye infections are at a higher risk of developing complications.

The risks of implantation with the Crystalens^® AO IOL include the same risks that exist for all cataract surgery with IOL implantation. However, because Crystalens contains hinges, there is an additional risk of the lens becoming stuck in an undesired position (vaulting). Vaulting is typically associated with blurry vision. This blurriness may occur suddenly or gradually. If your vision becomes blurred, contact your eye doctor immediately. Vaulting is most commonly treated via a secondary surgery, which has additional risks. Sometimes vaulting requires IOL removal and replacement.

The effectiveness of ultraviolet light absorbing lenses in reducing the incidence of retinal disorders has not been established. Unlike your crystalline lens and most IOLs that are currently available in the United States, Crystalens does not absorb a significant amount of ultraviolet light. Therefore, you should wear sunglasses with UV 400 protection when in sunlight.
The long term safety and effectiveness of this lens have not been proven.

This is not all you need to know. Please see the FDA Patient Information Brochure for additional information and discuss any questions with your eye doctor.

TRULIGN^® toric posterior chamber IOL

Indications

TRULIGN^® toric posterior chamber intraocular lens (IOL) is for use in adult patients to correct astigmatism with reduced need for glasses and improved uncorrected near, intermediate and far (distance) vision after cataract removal. Your eye doctor will advise you about the potential risks and benefits of cataract removal and IOL implantation.

Important Safery Information

Cataract surgery is one of the most common surgical procedures performed; however, as with all surgeries there are warnings, precautions, and risks that you should be aware of.

• Your eye doctor may not be able to implant the TRULIGN^® Toric IOL into your eye if you have complications during surgery before insertion (e.g. tissue damage that may interfere with proper positioning or functioning of the IOL). Depending on your complications your doctor may or may not be able to implant a different IOL during the same surgical procedure.
• Contact your eye doctor immediately if you have any of the following symptoms while using the antibiotic eye drops prescribed by your doctor: itching, redness, watering of your eye, sensitivity to light. These symptoms could indicate a potential serious eye infection.
• Possible complications from cataract surgery include infection, damage to the lining of the cornea, separation of the retina from the layer of tissue at the back of the eye, inflammation or swelling inside or outside the eye, damage to the colored part of your eye (iris), and an increase in eye pressure. You may need additional surgery to reposition or replace the IOL, or to treat other surgery complications. Toric IOLs require surgical repositioning more often than non-toric IOLs.
• Tell your eye doctor if you have been diagnosed with any eye disease. The outcome of cataract surgery will depend on the health of your eye before surgery.
• Tell your eye doctor if you have had prior refractive surgery, such as LASIK.
• You will need to wear glasses if you have: nearsightedness or farsightedness after surgery; uncorrected astigmatism after surgery; if you must do prolonged reading or read small print, you are likely to need reading glasses.
• If the toric lens is not positioned correctly following surgery, the change in your astigmatism correction by the IOL, along with any necessary correction with glasses, may cause visual distortions (for example, some objects may appear tilted / misshapen or floors may appear curved).
• Avoid any activity that could harm your eye (such as where objects can come in contact with or put pressure on the eye, such as tennis or scuba diving) while you are recovering from surgery.
• The TRULIGN^® Toric IOL contains hinges. There are side effects where the lens moves and the hinges get stuck in an undesired position (called vaulting). This usually causes blurry vision. If your vision becomes blurred, contact your eye doctor immediately

Potential Risks

Complications may occur as a result of the removal of your cataract whether or not an intraocular lens is implanted. Complications of cataract surgery range from minor, usually temporary side

effects, to sight-threatening complications. These complications are extremely rare and include, but are not limited to: infection, hemorrhage, and retinal detachment. People with medical conditions such as diabetes and chronic eye infections are at a higher risk of developing complications.

You may have reactions to medicines that may be prescribed to you after your eye surgery, and side effects including redness, scratchiness of the eye, and sensitivity to light. Possible complications from cataract surgery include infection, bleeding, inflammation, tissue damage, tissue swelling of the front or back of the eye, or an increase in eye pressure. If your lens is not in the correct position, your vision may also be affected and the normal flow of fluid within the eye may be blocked. You may require additional surgery to treat these side effects

If your doctor determines that the hinges in your TRULIGN^® Toric IOL have become stuck in an undesired position (in other words, the IOL has vaulted), the most common treatment is to have a secondary surgery, which has additional risks. Sometimes vaulting requires IOL removal and replacement.

This is not all you need to know. Please see the FDA Patient Information Brochure for additional information and discuss any questions with your eye doctor.

enVista Preloaded IOL (Model MX60PL) with SimplifEYE™

Indications

The enVista one-piece hydrophobic acrylic IOL (Model MX60PL) is indicated for primary implantation in the capsular bag of the eye in adult patients for visual correction of aphakia following removal of a cataractous lens for improved uncorrected distance vision. The SimplifEYE™ Inserter is indicated for folding and inserting of enVista IOLs (Models MX60PL and MX60PT) and IOL models approved for use with this IOL insertion device.

Warnings

Physicians considering lens implantation under any of the following circumstances should weigh the potential risk/benefit ratio:

1. Recurrent severe anterior or posterior segment inflammation or uveitis.
2. Patients in whom the intraocular lens may affect the ability to observe, diagnose, or treat posterior segment diseases.
3. Surgical difficulties at the time of cataract extraction, which might increase the potential for complications (e.g., persistent bleeding, significant iris damage, uncontrolled positive pressure, or significant vitreous prolapse or loss).
4. A distorted eye due to previous trauma or developmental defect in which appropriate support of the IOL is not possible.
5. Circumstances that would result in damage to the endothelium during implantation.
6. Suspected microbial infection.
7. Patients in whom neither the posterior capsule nor zonules are intact enough to provide support.

Precautions

1. Do not attempt to resterilize the lens or inserter as this can produce undesirable side effects.
2. Do not use if product sterility or quality is thought to be compromised due to damaged packaging or signs of leakage (such as the loss of saline storage solution, or the presence of salt crystallization).
3. Do not soak or rinse the intraocular lens with any solution other than sterile balanced salt solution or sterile normal saline.
4. Do not store the lens or inserter at a temperature greater than 43 ̊C (109 ̊F) or lower than 0 ̊C (32 ̊F). Do not autoclave the intraocular lens.
5. Do not re-use the lens or inserter. It is intended for permanent implantation. If explanted, sterility and proper function cannot be assured.
6. The safety and effectiveness of the enVista IOL have not been substantiated in patients with pre-existing ocular conditions and intraoperative complications (see below). Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to decide the benefit/risk ratio before implanting a lens in a patient with one or more of these conditions. Physicians considering lens implantation in such patients should explore the use of alternative methods of aphakic correction and consider lens implantation only if alternatives are deemed unsatisfactory in meeting the needs of the patient.

   Before Surgery

   • Retinal conditions or predisposition to retinal conditions, previous history of, or a predisposition to, retinal detachment or proliferative diabetic retinopathy, in which future treatment may be compromised by implanting this lens.
   • Amblyopia
   • Clinically severe corneal dystrophy (e.g., Fuchs’)
   • Rubella, congenital, traumatic or complicated cataracts
   • Extremely shallow anterior chamber, not due to swollen cataract
   • Recurrent anterior or posterior segment inflammation of unknown etiology, or any disease producing an inflammatory reaction in the eye (e.g. iritis or uveitis).
   • Aniridia
   • Iris neovascularization
   • Glaucoma (uncontrolled or controlled with medication)
   • Microphthalmos or macrophthalmos
   • Optic nerve atrophy
   • Previous corneal transplant
   • Pre-existing ocular conditions which may negatively impact stability of the implant.

   During Surgery

   • Mechanical or surgical manipulation required to enlarge the pupil
   • Vitreous loss (significant)
   • Anterior chamber bleeding (significant)
   • Uncontrollable positive intraocular pressure
   • Complications in which the IOL stability could be compromised
7. Patients with preoperative problems such as corneal endothelial disease, abnormal cornea,macular degeneration, retinal degeneration, glaucoma, and chronic drug miosis may not achieve the visual acuity of patients without such problems. The physician must determine the benefits to be derived from lens implantation when such conditions exist.
8. A high level of surgical skill is required for intraocular lens implantation. The surgeon should have observed and/or assisted in numerous implantations and successfully completed one or more courses on intraocular lens implantation before attempting to implant intraocular lenses.
9. Care should be taken to remove viscoelastic from the eye at the close of surgery.

Medical Device Re-use Statement

If this product is reprocessed and/or re-used, Bausch + Lomb cannot guarantee the functionality, material structure, or cleanliness or sterility of the product. Re-use could lead to illness, infection and/or injury to the patient or user and, in extreme incidents, death. This product is labeled as ‘single-use’ which is defined as a device intended to be used once only for a single patient.

Adverse Events

The incidence of adverse events experienced during the clinical trial was comparable to or lower than the incidence reported in the historic control (“FDA grid”) population. The enVista IOL demonstrated favorable safety compared with the Control IOL and the historical control (cf. ISO 11979-7 SPE) population, with no increase in incidence or severity of adverse events (AEs) compared with the Control IOL and no serious adverse events (SAEs) in the study eye. Overall, no safety signals were associated with the IOLs during this study. As with any surgical procedure, risk is involved. Potential adverse events accompanying cataract or implant surgery may include, but are not limited to, the following: corneal endothelial damage, infection (endophthalmitis), retinal detachment, vitritis, cystoid macular edema, orneal edema, pupillary block, cyclitic membrane, iris prolapse, hypopyon, transient or persistent glaucoma, acute corneal decompensation, toxic anterior segment syndrome (TASS), and secondary surgical intervention. Secondary surgical interventions include, but are not limited to: lens repositioning, lens replacement, vitreous aspiration or iridectomy for pupillary block, wound leak repair, and retinal detachment repair.

enVista Aspire™ Toric IOL

Indications

The enVista Aspire™ toric hydrophobic acrylic IOL (non-preloaded model ETA) is indicated for primary implantation in the capsular bag of the eye in adult patients for the visual correction of aphakia and corneal astigmatism following the removal of a cataractous lens for improved uncorrected distance vision.

Device Description

The Aspire IOL uses an optical modification of the posterior aspheric surface to create a small continuous increase in IOL power within the central 1.5 mm diameter to slightly extend the depth of focus. However, clinically meaningful extension of the depth of focus has not been demonstrated in clinical trials.

Warnings

Physicians considering IOL implantation under any of the following circumstances should weigh the potential risk/benefit ratio: (1) Recurrent severe anterior or posterior segment inflammation or uveitis; (2) Patients in whom the IOL may affect the ability to observe, diagnose, or treat posterior segment diseases; (3) Surgical difficulties at the time of cataract extraction, which might increase the potential for complications (e.g., persistent bleeding, significant iris damage, uncontrolled positive pressure, or significant vitreous prolapse or loss); (4) A distorted eye due to previous trauma or developmental defect in which appropriate support of the IOL is not possible; (5) Circumstances that would result
in damage to the endothelium during implantation; (6) Suspected microbial infection; (7) Patients in whom neither the posterior capsule nor zonules are intact enough to provide support; (8) Rotation of the IOL away from the intended axis can reduce its astigmatic correction. Misalignment greater than 30° may increase postoperative refractive cylinder. If necessary, IOL positioning should occur prior to capsule fibrosis and IOL encapsulation.

Precautions

1. Neither the safety and effectiveness, nor the effects of the Aspire IOL optical design on depth of focus, contrast sensitivity, and subjective visual disturbances (glare, halo, etc.) have been evaluated clinically. MTF testing of the Aspire IOL optical design (used in model ETA) may aid the surgeon in understanding the theoretical image quality expected with the Aspire IOL compared to the enVista monofocal IOL MX60E. However, these do not fully assess all aspects of clinical difficulties under all conditions. Surgeons must weigh the potential benefits of the modified optical design of the Aspire IOL (model ETA) against the potential for risks associated with a degradation in vision quality and the lack of clinical data to characterize the impact of the Aspire IOL optical design on contrast sensitivity and subjective visual disturbance. These considerations may be especially relevant to patients with certain pre-existing ocular conditions (prior corneal refractive surgery, irregular corneal astigmatism, severe corneal dystrophy, macular disease, optic nerve atrophy, etc.) or intraoperative conditions (posterior capsular rupture, complications in which the IOL stability could be compromised, inability to place IOL in capsular bag, etc).
2. The safety and effectiveness of the IOL have not been substantiated in patients with pre-existing ocular conditions and intraoperative complications. Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to decide the benefit/risk ratio before implanting an IOL in a patient with one or more of these conditions. Physicians considering IOL implantation in such patients should explore the use of alternative methods of aphakic correction and consider IOL implantation only if alternatives are deemed unsatisfactory in meeting the needs of the patient.
3. Patients with preoperative problems, such as corneal endothelial disease, abnormal cornea, macular degeneration, retinal degeneration, glaucoma, and chronic drug miosis may not achieve the visual acuity of patients without such problems. The physician must determine the benefits to be derived from IOL implantation when such conditions exist.

Adverse Events

As with any surgical procedure, there is risk involved. Potential complications accompanying cataract or implant surgery may include, but are not limited to the following: corneal endothelial damage, infection (endophthalmitis), retinal detachment, vitritis, cystoid macular edema, corneal edema, pupillary block, cyclitic membrane, iris prolapse, hypopyon transient or persistent glaucoma, and secondary surgical intervention. Secondary surgical interventions include but are not limited to: lens repositioning, lens replacement, vitreous aspiration or iridectomy for pupillary block, wound leak repair, and retinal detachment repair.

CAUTION: Federal law restricts this device to sale by or on the order of a physician.

ATTENTION: This is not all you need to know. Please refer to the Directions For Use labeling for a complete listing of indications, full risk and safety information, clinical study information, etc.

enVista Envy™ non-toric & toric IOL

Indications

The enVista Envy hydrophobic acrylic IOL is indicated for primary implantation in the capsular bag of the eye in adult patients for visual correction of aphakia with less than or equal to 1.0 D preoperative corneal astigmatism following removal of a cataractous lens to mitigate the effects of presbyopia by providing improved intermediate and near visual acuity, while maintaining comparable distance visual acuity to an aspheric monofocal IOL. 

The enVista Envy toric hydrophobic acrylic IOL is indicated for primary implantation in the capsular bag of the eye in adult patients for visual correction of aphakia and corneal astigmatism following removal of a cataractous lens to mitigate the effects of presbyopia by providing improved intermediate and near visual acuity, while maintaining comparable distance visual acuity to an aspheric monofocal IOL. 

Warnings/Precautions

Physicians should weigh the potential risk/benefit ratio before implanting the enVista Envy lens under any of the circumstances or conditions outlined in the Instructions for Use labeling. Some visual disturbances may be expected due to the superposition of focused and unfocused multiple images. These may include some perceptions of halos or radial lines around point sources of light (starbursts) under nighttime conditions, glare, double vision, haziness and blurred vision. It is expected that, in a small percentage of patients, the observation of such phenomena will be annoying and may be perceived as a hindrance, particularly in low illumination conditions such as nighttime driving. As with other trifocal IOLs, there is a possibility that visual disturbances may be significant enough that the patient will request explant of the IOL. A reduction in contrast sensitivity as compared to a monofocal IOL may be experienced by some patients, therefore, patients implanted with trifocal IOLs should exercise caution when driving at night or in low light or poor visibility conditions. Care should be taken to achieve IOL centration as IOL decentration may result in patients experiencing visual disturbances or suboptimal vision under certain lighting conditions. The surgeon must target emmetropia to achieve optimal visual performance. Patients should be advised that unexpected outcomes could lead to continued spectacle dependence or the need for secondary surgical intervention (e.g., intraocular lens replacement or repositioning). Please provide a copy of the Patient Information Brochure, which can be found at www.bausch.com/IFU. Posterior capsule opacification (PCO) may significantly affect the vision of patients with multifocal IOLs earlier in its progression than patients with monofocal IOLs. This may be due to the reduced contrast sensitivity observed with multifocal IOLs. 

Additional Precautions for Toric IOLs: The enVista Envy Toric IOL has not been evaluated in a clinical study. In general, astigmatism that is corrected with a higher cylinder power IOL can result in clinically significant residual astigmatism. The effect of residual astigmatism at distance, intermediate, and near was evaluated in a clinical study of patients who had been implanted with non-toric enVista Envy IOLs and were induced with cylinder power to simulate various levels of residual astigmatism. If a secondary surgical intervention is necessary to reposition the IOL, explantation should be considered as some patients may have recurrent or persistent issues related to rotational instability and misalignment.  

CAUTION: Federal law restricts this device to sale by or on the order of a physician.

ATTENTION: See the Directions for Use for a complete listing of indications and important safety information.
 

FortifEYE^® Capsular Tension Ring

Description

The Bausch + Lomb FortifEYE^® CTR is a sterile capsular tension ring (CTR) that is preloaded into a single-use injector. The FortifEYE^® preloaded single use injector is an auxiliary device which simplifies the implantation of the FortifEYE^® capsular tension ring.

Indications

For the stabilization of the crystalline lens capsule in the presence of weak or partially absent zonules in adult patients undergoing cataract extraction with intraocular lens implantation. Conditions associated with weak or partially absent zonules may include primary zonular weakness (e.g., Marfan’s Syndrome), secondary zonular weakness (e.g., trauma or vitrectomy), cases of zonulysis, cases of pseudoexfoliation and cases of Marchesani’s Syndrome.

Contraindications

The capsular tension ring should not be used in children 12 years of age or younger since this device is contraindicated in eyes still growing. The FortifEYE^® CTR is contraindicated for patients with perforated or damaged capsules.

Warnings

The effect of the capsular tension ring on the progression of zonular instability over time is unknown at this date. Eyes with pseudoexfoliation syndrome and decreased anterior chamber depth exhibit a greater likelihood of zonular instability at the time of surgery and an increased probability of intraoperative complications. Since the number of eyes with zonular dehiscence greater than 50 % was very low (13/316, 4 %), no scientific conclusions can be drawn regarding the probable visual outcome in this population, especially in the presence of other preoperative pathologies. The physician should use his/her own discretion in utilizing the FortifEYE^® CTR in these cases.

Precautions

Do not use the Bausch + Lomb FortifEYE^® CTR if the sterilized package is open or damaged. The capsular tension ring should not be used after the expiration date indicated. Do not re-sterilize the implant or the injector by any method. Do not reuse the implant or the injector. Rinse the implant only with sterile intraocular rinsing solutions such as sterile Ringer's solution or sterile balanced salt solution. Store only at room temperature. Do not expose to extreme temperatures. The injector must only be used with the implant provided with it.

ATTENTION: Refer to the Directions for Use labeling for a complete listing of indications, warnings and precautions, clinical trial information, etc.

CAUTION: Federal (USA) law restricts this device to the sale by or on the order of a physician.

IC-8^® Apthera™ IOL

Indications

The IC-8^® Apthera™ IOL is indicated for unilateral implantation for the visual correction of aphakia and to create monovision in patients of age 22 or older who have been diagnosed with bilateral operable cataract, who have up to 1.5 D of astigmatism in the implanted eye, and who do not have a history of retinal disease and who are not predisposed to experiencing retinal disease in the future. The device is intended for primary implantation in the capsular bag, in the non-dominant eye, after the fellow eye has already undergone successful implantation (uncorrected distance visual acuity 20/32 or better and best-corrected distance visual acuity 20/25 or better) of a monofocal or monofocal toric IOL that is targeted for emmetropia. The refractive target for the IC-8 Apthera IOL should be -0.75 D. The lens mitigates the effects of presbyopia by providing an extended depth of focus. Compared to an aspheric monofocal or monofocaltoric IOL, the lens provides improved intermediate and near visual acuity, while maintaining comparable distance visual acuity.

Contraindications

(1) Patients with dilated pupil size less than 7.0 mm. (2) Patients with a history of retinal disease including but not limited to, high myopia, diabetes, macular disease, sickle cell disease, retinal tear, retinal detachment, retinal vein occlusion, ocular tumor, uveitis, and patients who are predisposed to experiencing retinal disease in the future.

Warnings

The lens should not be implanted if appropriate intraocular support of the lens is not possible. Severe subjective visual disturbances (e.g., glare, halo, starburst, hazy vision) may occur after device implantation. There is a possibility that these visual disturbances may be significant enough that a patient may request removal of the lens. Contrast sensitivity in eyes implanted with this lens is significantly reduced when compared to the fellow eye implanted with a monofocal or monofocal toric IOL. Although there was no significant reduction in binocular contrast sensitivity in the IDE clinical study, it is essential that prospective patients be fully informed of this visual effect in the implanted eye before giving their consent for unilateral implantation of the lens. Patients should be informed that they may need to exercise caution when engaging in activities that require good vision in dimly lit environments (such as driving at night or in poor visibility conditions). There is a possibility that visual symptoms due to reduced contrast sensitivity may be significant enough that a patient may request removal of the lens. This lens should not be implanted bilaterally because bilateral implantation is expected to cause significant reduction in contrast sensitivity under all lighting conditions. The use of this lens in patients with corneal astigmatism greater than 1.5 D is not recommended. Diagnostic tests in patients implanted with the lens may take longer and require some additional effort from the patient and the physician to perform. Use of some medical lasers to treat certain eye conditions may present potential risks of damaging the FilterRing component of the lens. Removal of the lens may be necessary prior to retinal or vitreal procedures. Surgeons should perform a careful benefit-risk assessment based on individual patient characteristics, weighing all the risks disclosed in the Directions for Use labeling against the benefit of extended depth of focus. Nd:YAG laser capsulotomy treatments may be more difficult to perform and may be less effective in an IC-8^® Apthera™ IOL implanted eye. Specific training from Bausch & Lomb, Inc. or its authorized representative related to YAG capsulotomy is required before a surgeon is authorized to implant the IC-8^® Apthera™ IOL.

Precautions

Prior to surgery, prospective patients should be informed of the possible risks and benefits associated with this lens and a Patient Information Brochure should be provided to the patient. Patients with a predicted postoperative astigmatism between 1.0 D and 1.5 D may not obtain as great an amount of improvement in intermediate vision compared to patients with lower amounts of astigmatism.

Caution: Federal law restricts this device to sale by or on the order of a licensed physician.

Attention: Reference the Directions for Use labeling for a complete listing of important safety information.

SofPort^® Intraocular Lenses

Indications

The LI61AO and LI61SE SofPort^® lenses are intended to be used for primary implantation for the visual correction of aphakia in adult patients where a cataractous lens has been removed by extracapsular cataract extraction methods (see WARNINGS). They are intended for placement in the ciliary sulcus or capsular bag. NOTE: Implantation of intraocular lenses should not be performed in patients under 18 years of age.

Warnings

As with any surgical procedure, there is risk involved. Potential complications accompanying cataract or implant surgery may include but are not limited to the following: lens dislocation, manifestations of inflammation, corneal endothelial damage, infection (endophthalmitis), retinal detachment, vitritis, cystoid macular edema, corneal edema, pupillary or cyclitic membrane, iris prolapse, hypopyon, and transient or persistent glaucoma. The safety and efficacy of these posterior chamber lenses have not been established if placed in the anterior chamber. Pupillary block may be prevented by one or more iridectomies performed at the time of implantation. The long-term effects of intraocular lens implantation have not been determined. Undesirable optical effects such as glare, halos, etc. have been reported by some patients after intraocular Iens implantation. These phenomena are not completely understood but are thought to be related to positioning holes and edge effects. The effectiveness of these lenses in reducing the incidence of retinal disorders has not been established. The safety of intraocular lenses has not been substantiated in patients with pre-existing ocular conditions (chronic drug miosis, glaucoma, amblyopia, diabetic retinopathy, previous corneal transplant, previous retinal detachment, iritis, etc.). Physicians considering lens implants in such patients should explore the use of alternative methods of aphakic correction and consider lens implantation only if alternatives are deemed unsatisfactory to meet the needs of the patient. Patients with preoperative problems such as corneal endothelial disease, abnormal cornea, macular degeneration, glaucoma, and chronic drug miosis may not achieve the visual acuity of patients without such problems. The physician must determine the benefits to be derived from lens implantation when such conditions exist. Patients who experience surgical complications associated with the cataract extraction procedure (posterior capsule rupture, detached Descemet’s membrane, anterior chamber bleeding, iris damage, or vitreous bulge or loss) may experience poorer visual acuity. Medical judgment must be exercised to determine if a lens should be implanted when surgical problems occur. Patients who experience postoperative complications, particularly macular edema, may have a slightly higher risk of experiencing poorer visual outcome than patients without sight-threatening complications. This lens is not intended, nor should be used, for a clear lens exchange.

Precautions

Do not resterilize these lenses by any method. Do not store lenses at temperatures over 45°C. Use only sterile intraocular irrigating solutions, e.g., balanced salt or normal saline solution, to rinse and/or soak lenses. The lens should be handled carefully. Do not use serrated or toothed instruments or apply undue pressure when handling silicone lenses as doing so may damage the lenses. The lens must be discarded if it remains in the folding instrument longer than 15 minutes. Special consideration should be given to the dimensions of lenses at the extreme ends of the power range in relation to the anatomical clearances in the patient’s eye. The potential impact of factors such as optic central thickness, optic edge thickness, and overall lens size on the patient's long-term clinical outcome should be carefully weighed against the potential benefit associated with the implantation of an intraocular lens. This is particularly true for anterior chamber lenses. The patient's clinical progress should be carefully monitored. Do not use forceps to fold lenses with more than 30.0 diopters due to the high central thickness. Lens can be inserted flat with forceps, or with an approved injector.

Adverse Events

The most frequently reported adverse events that occurred during the clinical trial of the SofPort^® were hypopyon, intraocular infection and acute corneal decompensation all of which occurred at a rate of <0.5%. Other reported events occurring in less than 1% of patients were secondary surgical interventions.

CAUTION: Federal law restricts this device to sale by or on the order of a physician.

ATTENTION: Reference the Directions for Use labeling for a complete listing of indications and important safety information.

Stellaris Elite^® and Accessories

Indications

The Bausch + Lomb Stellaris Elite^® vision enhancement system is intended for the emulsification and removal of cataracts, anterior and posterior segment vitrectomy. The system is designed for use in both anterior and posterior segment surgeries. It provides capabilities for phacoemulsification, coaxial and bimanual irrigation/aspiration, bipolar coagulation, vitrectomy, viscous fluid injection/removal and air/fluid exchange operations. The Stellaris Elite^® Vision Enhancement System configured with the laser module is additionally intended for retinal photocoagulation and laser trabeculoplasty.

Contraindications

• All Models: Use of accessories not designated by Bausch + Lomb for use with this equipment may result in serious permanent patient injury, adverse surgical outcome, or damage to the equipment.
• Systems with Laser Module: Photocoagulation is not indicated for patients without pigmentation (albino eyes). In addition, Laser Indirect Ophthalmoscope (LIO) is not indicated for cases involving laser photocoagulation within the arcades.

Warnings

• All Systems:
  • Implantable defibrillators present a risk of injury if triggered by a fibrillatory event during intraocular surgery, due to involuntary motion by the patient. Patients being considered for intraocular procedures must be questioned to determine if they have such a device, and, if so, the defibrillator manufacturer must be consulted to determine the appropriate action.
  • Electromagnetic interaction between the phacoemulsification (phaco) handpiece and an implanted cardiac pacemaker is unlikely but cannot be ruled out. Patients should be questioned to determine if they have such an implant, and, if so, the manufacturer of the implant should be consulted to determine the proper course of action.
• Systems with Laser Module:
  • All support personnel who are present during laser treatment must wear appropriate laser protective eyewear.
  • The laser protective eyewear provided is not optimized for the aiming beam. DO NOT look directly into the aiming beam even with laser protective eyewear.
  • Never look directly into the fiber optic cable which delivers the aiming or treatment laser beam, with or without laser safety eyewear.
  • The use of unapproved delivery devices may cause inaccurate laser delivery which could result in serious permanent patient injury. Use only approved delivery devices.
• When using the VITESSE^® Handpiece for vitrectomy in the posterior segment of the eye: o Use only the Entry Site Alignment (ESA) devices provided with the VITESSE^®
  • Handpiece Pack (yellow trocar caps). Do not use any ESA with metal components to avoid particulate in the eye.
• When using the FREEFLOW™ infusion line:
  • Do not attempt to administer intraocular gases or viscous fluids using this device. This device is only to be used for the controlled delivery of infusion fluid.
  • The infusion line loop is only required for freedom of motion, not orientation. Therefore, unlike traditional infusion lines, the loop should be created in the horizontal plane to reduce the risk of disengaging the infusion line from the infusion cannula.

General Cautions for Single Use Accessories

• Do not re-sterilize or reuse any single use accessories, including but not limited to infusion lines, components of an anterior vitrectomy pack, such as air lines, irrigation lines, aspiration lines, or vitrectomy cutters.
• Do not use single use products if package integrity / sterile barrier has been breached or compromised.
• Do not use or attempt to repair damaged single use products.

This is not all you need to know. Systems with Laser Module: Misuse of the laser system may lead to dangerous situations and severe injuries. All Systems: See the appropriate Operator Manual for detailed directions, proper use, and full risk and safety information. See individual product instructions for use for detailed information on the use of the VITESSE^® handpiece, vitrectomy packs, vitrectomy cutters, and the FREEFLOW™ infusion line.

CAUTION: Federal (U.S.) Law restricts these devices to sale, by or on the order of a physician.

Warning: Class 4 Laser Product - Visible laser radiation, avoid eye or skin exposure to direct or scattered radiation. Additionally contains a Class 2 aiming beam laser component.

TENEO™

Indications for Use

The Technolas Teneo 317 Model 2 is indicated for laser-assisted in situ keratomileusis (LASIK) in: (1) Patients for the reduction or elimination of myopic astigmatism up to -10.00 D MRSE, with sphere between -1.00 D and cylinder between 0.00 and -3.00 D; (2) Patients who are 22 years of age or older; (3) Patients must have a stable refraction in the last 12 months, as documented by previous clinical recordings, i.e., the spherical and cylindrical portions of the manifest distance refraction have not progressed at a rate of more than 0.50 D per year prior to the baseline examination in the eye(s) to be treated.

Warning

Danger of injury due to failure to observe the patient selection criteria! Failure to observe the contraindications and potential adverse effects may result in serious permanent patient injury. The usage of the laser system is limited to a specific field of applications. Observe the contraindications and potential adverse effects listed in the User Manual before selecting a patient and starting any treatment.

Contraindications

Contraindications of the Technolas Teneo 317 Model 2 include patients: (1) with any type of active connective tissue disease or autoimmune disease; (2) with signs of keratoconus, abnormal corneal topography, and degenerations of the structure of the cornea (including but not limited to pellucid marginal degeneration); (3) with significant dry eyes (severe Dry Eye Syndrome). If patients have severely dry eyes, LASIK may increase the dryness. This may or may not go away. Severe eye dryness may delay healing of the flap or interfere with the surface of the eye after surgery. It may result in poor vision after LASIK; (4) for whom the combination of their baseline corneal thickness and the planned operative parameters for the LASIK procedure would result in less than 250µ of residual corneal thickness from corneal endothelium; (5) with uncontrolled diabetes; (6) with uncontrolled glaucoma; (7) with active eye infections or active inflammation: (8) with recent herpes eye infection or problems resulting from past infections; (9) with known sensitivity to medications used for standard LASIK surgery.

Potential Risks and Side Effects

(1) Miscreated flap; (2) Subconjunctival hemorrhage or bleeding; (3) Wrinkles in flap that may require a flap lift; (4) Corneal erosion/abrasion, epithelia defect; (5) Elevated IOP; (6) Debris or foreign body under flap; (7) Epithelial ingrowth under flap; (8) Debilitating visual symptoms, especially at night; (9) Decreased or fluctuating visual acuity; (10) Decreased ability to see in low-light conditions; (11) Light sensitivity; (12) Dry Eye syndrome; (13) Inadequate treatment result; (14) Regression; (15) Corneal damage; (16) Posterior vitreous detachment or retinal detachment, floaters or vascular accidents; (17) Foreign body sensation or pain (initial postoperative days); also, potentially including chronic eye pain that is resistant to therapy referred to as neuropathic pain; (19) Infection/inflammation; (20) CTK (Central Toxic Keratopathy); (21) Medication intolerance; (22) Ptosis; (23) Cataract; (24) Ocular penetration; (25) Potential risk of psychological harm.

This is not all you need to know. Please see the User Manual for a complete list of safety information, including a full list of contraindications, warnings, precautions and risks.

Caution: Federal (U.S.) law restricts this device to sale, by or on the order of a physician.

VICTUS^® femtosecond laser platform

Indications for Use

The VICTUS^® femtosecond laser platform is indicated for use for:

• The creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea
• For anterior capsulotomy during cataract surgery
• The creations of cuts / incisions in the cornea of patients undergoing cataract surgery or other ophthalmic treatment requiring cuts / incisions in the cornea
• Laser-assisted lens fragmentation of nuclear cataracts during cataract surgery, not for posterior subcapsular (PSC) and cortical cataracts

Safety Information

The VICTUS^® femtosecond laser platform emits an invisible class 3B laser beam that may injure the retina of the eyes or burn the skin. Never look directly into the laser source.

Misuse of the laser system may lead to dangerous situations and severe injuries. See the Operator Manual for detailed directions, proper use, and full risk and safety information.

Contraindications

General contraindications for using the VICTUS^® femtosecond laser platform include, but are not limited to:

• Pediatric surgery, hypotony, glaucoma, retinal disorders, rheumatic diseases, occlusion of retinal vessels, pellucid marginal degeneration, existing corneal implant, heavy vascularization of the ocular tissue, or epilepsy.
• Conditions that would cause inadequate clearance between the intended capsulotomy cut and the corneal endothelium, such as chemosis, significant loss of stability of the conjunctiva, and nystagmus.
• Subjects with corneal disease or pathology that precludes applanation of the cornea or transmission of laser wavelength or distortion of laser light, such as: residual, recurrent, active ocular or uncontrolled eyelid disease or any corneal abnormalities (including endothelial dystrophy, guttata, recurrent corneal erosion, etc.) in the eye to be treated; ophthalmoscopic signs of keratoconus (or keratoconus suspect) in the eye to be treated; a history of herpes zoster or herpes simplex keratitis; or subjects who are using ophthalmic medication(s) other than artificial tears for the treatment of ocular pathology including ocular allergy, or any corneal disease in the fellow eye that requires treatment (recurrent corneal erosion, severe basement membrane disease).
• Patients who are pregnant or nursing, are blind in the fellow eye, or have a known sensitivity to planned concomitant medication.
• Patients with a difference of more than 5D between minimum and maximum K-values of the central 3mm zone on a keratometric map of the cornea, maximum K-value of more than 60D, or minimum K-value of less than 37D.

General contraindications for using the VICTUS^® femtosecond laser platform to perform anterior capsulotomy include, but are not limited to:

• Patients with a poorly dilating pupil, anterior chamber depth (ACD) <1.5mm or ACD >4.8 mm as measured by ultrasonic examination, less than 40 years of age, previous corneal surgery of any kind, dry eye diseases, severe wound-healing disorders (such as connective tissue disease, autoimmune illnesses, immunodeficiency illnesses, endocrine diseases, lupus, rheumatoid arthritis), diabetes mellitus, severe acne rosacea, or patients suffering from AIDS or HIV.

General contraindications for using the VICTUS^® femtosecond laser platform to perform lens fragmentation include, but are not limited to, the following:

• Patients with a poorly dilating pupil, anterior chamber depth (ACD) <1.5mm or ACD >4.8 mm as measured by ultrasonic examination, history of lens or zonular instability, less than 40 years of age, posterior subcapsular (PSC) or cortical cataracts.

General contraindications for using the VICTUS^® femtosecond laser platform to perform corneal incisions include, but are not limited to, the following:

• Dry eye diseases, previous corneal surgery, specifically incisions that might provide a potential space into which the gas produced by the procedure can escape, or corneal thickness requirements that are beyond the range of the system.

General contraindications for using the VICTUS^® femtosecond laser platform to flaps for LASIK include, but are not limited to, the following:

• Anyone who is not eligible for a laser vision correction (LVC), patient under the age of 18 years or legal age, previous corneal surgery of any kind, dry eye diseases, cataract, diabetes mellitus, severe wound-healing disorders (connective tissue disease, autoimmune illnesses, immunodeficiency illnesses, endocrine diseases, lupus, rheumatoid arthritis, etc.), patients with an autoimmune disease, collagenosis, or clinically significant atopy, patients suffering from AIDS or HIV, or patients with signs of progressive or unstable myopia in the eye that require treatment.

Potential Complications

Potential general complications resulting from VICTUS procedures include, but are not limited to the following:

• Corneal abrasion or defect, pain, bleeding, inflammation, or elevated intraocular pressure.

Potential complications resulting from anterior capsulotomy or lens fragmentation include, but are not limited to the following:

• Capsulotomy decentration, incomplete or interrupted capsulotomy or lens fragmentation, decentered intraocular lens (IOL), capsular tear, or damage to intraocular structures.

Potential complications resulting from the creation of corneal flaps or corneal cuts / incisions include, but are not limited to the following:

• Corneal edema, epithelial ingrowth, flap or corneal cuts / incisions decentration, incomplete flap or corneal cuts / incisions creation
• Flaps only: flap tearing or incomplete lift-off, free cap, photophobia, thick or thin flaps, flap striae

Misuse of the laser system may lead to dangerous situations and severe injuries. See the Operator Manual for detailed directions, proper use, and full risk and safety information.

CAUTION: Federal (U.S.) Law restricts this device to sale, by or on the order of a physician.

Warning: Class 3B Laser Product - Invisible laser radiation, avoid eye or skin exposure to direct or scattered radiation.Warning:  Class 3B Laser Product - Invisible laser radiation, avoid eye or skin exposure to direct or scattered radiation.