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INDICATIONS AND IMPORTANT SAFETY INFORMATION

INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR THE TECNIS^® 1-PIECE MONOFOCAL IOLS

CAUTION

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

ATTENTION

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

INDICATIONS

TECNIS^® 1-Piece lenses are indicated for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. These devices are intended to be placed in the capsular bag.

WARNINGS

Existing eye conditions and surgical difficulties may increase the risk of complications. Your doctor will determine if you are a good candidate for lens replacement.

PRECAUTIONS

If your eye is not healthy, you may not get the full benefits of the TECNIS^® 1-Piece IOL. Before surgery your doctor will check to see if you have any eye diseases. If you wear contact lenses, your doctor may ask you to stop wearing them before being tested for the lens. Your doctor will tell you what activities to avoid while you are recovering from surgery. A monofocal lens may give you excellent far vision, but you may still need glasses for activities requiring near vision.

SIDE EFFECTS

In less than 4% of patients, side effects of cataract surgery with the 1-Piece IOL included macular edema, a swelling/thickening of an area of the retina. In less than 1% of patients, there was a need for a second surgery to replace, reposition, or remove the new lens or to repair structures of the eye.

INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR THE TECNIS^® TORIC 1-PIECE IOL

CAUTION

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

ATTENTION

Reference the labeling for a complete listing of Important Indications and Safety Information.

INDICATIONS

The TECNIS^® Toric 1-Piece posterior chamber lenses are indicated for the visual correction of aphakia and pre-existing corneal astigmatism of one diopter or greater in adult patients with or without presbyopia in whom a cataractous lens has been removed by phacoemulsification and who desire improved uncorrected distance vision, reduction in residual refractive cylinder, and increased spectacle independence for distance vision. The device is intended to be placed in the capsular bag.

RISKS

No matter what lens you choose, there are risks or problems that can happen with cataract surgery. The problems could be minor, temporary, or affect your vision long term. Complications with cataract surgery are rare and may include the worsening of your vision, bleeding, or infection. Call your eye doctor right away if you experience any itching, pain, flashing lights, “floaters”, redness, severe headache, upset stomach, light sensitivity, or watery eyes after surgery.

WARNINGS

A Toric IOL corrects astigmatism when it is placed correctly in the eye. There is a chance that the Toric IOL could be placed incorrectly or could move within the eye. Your doctor may need to move the lens to the right position following surgery. If the Toric lens is not placed correctly, you may have visual distortions. A second surgery may be needed to properly position the lens. You should not receive this device if you have had previous trauma to your eye. Also, children under the age of two should not receive this device.

PRECAUTIONS

If your eye is not healthy (including glaucoma), you may not get the full benefits of the TECNIS^® Toric IOL. Before surgery your doctor will check to see if you have any eye diseases. There is a chance that you still may need glasses for distance vision with a Toric IOL. Take all prescribed medicines and apply eye drops as instructed. If you wear contact lenses, your doctor may ask that you stop wearing them before being tested for the lens. You should avoid any activity that could harm your eye while you are recovering from surgery. Your doctor will tell you what activities to avoid while you are recovering from surgery.

SIDE EFFECTS

In 3.4% of patients, side effects of cataract surgery with the TECNIS^® Toric 1-Piece clinical trials included the need for a second surgery to reposition the lens or repair the retina. Other side effects included swelling/thickening of the retina (2.9%), and separation of the retina from the surrounding tissues (less than 1%).

INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR THE TECNIS^® MULTIFOCAL FAMILY OF 1-PIECE IOLS

CAUTION

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

ATTENTION

Please see Directions for Use for a complete list of Indications and Important Safety Information.

INDICATIONS

The TECNIS^® Multifocal 1-Piece intraocular lenses are indicated for primary implantation for the visual correction of aphakia in adult patients with and without presbyopia in whom a cataractous lens has been removed by phacoemulsification and who desire near, intermediate, and distance vision with increased spectacle independence. The intraocular lenses are intended to be placed in the capsular bag.

RISKS

No matter what lens you choose, there are risks or problems that can happen with cataract surgery. The problems could be minor, temporary, or affect your vision permanently. Complications are rare and may include the worsening of your vision, bleeding, or infection. There are also tradeoffs with receiving a multifocal lens. Whereas your use of glasses may decrease, it may come at the cost of some sharpness of your vision. Even with glasses, this loss of sharpness may become worse under poor visibility conditions such as dim light or fog. You may also notice more halos (rings of light around a light source) or glare (scattered light effect around a light source), which are more common with multifocal IOLs than monofocal IOLs. Call your eye doctor right away if you experience any itching, pain, flashing lights, “floaters”, redness, severe headache, nausea/vomiting, light sensitivity, or watery eyes after surgery.

WARNINGS

A very small number of patients (less than 1% in U.S. clinical studies) may be dissatisfied and request removal of their multifocal IOL. Under poor visibility conditions, your vision may be reduced more than it would be with a monofocal IOL. Under these conditions, you may have more difficulty recognizing some traffic signs and hard-to-see objects in the road. Therefore, you may need to take extra care when driving, especially in poor light conditions. In rare instances, multifocal IOLs may make some types of retinal surgery more difficult. You should not receive this device if you have had previous trauma to your eye. Children under the age of 2 should not receive this device.

PRECAUTIONS

If your eye is not healthy (including glaucoma), your vision may not be good even after your cataract is removed. In this case, you may not get the full benefit of the multifocal IOL. Before surgery, your eye doctor will check to see if you have any eye diseases. There is a chance that your vision with a multifocal IOL may not be good enough to perform very near or detailed “up-close” work without glasses. Depending on the type of TECNIS^® Multifocal 1-Piece IOL you choose, the lens is designed for near vision from 13 to 20 inches. Take all prescribed medicines and apply eye drops as instructed. You should avoid any activity that could harm your eye while you are recovering from surgery. Your eye doctor will tell you what activities you should avoid. If you wear contact lenses, your eye doctor may ask you to stop wearing them before being tested for the multifocal IOL.

ADVERSE EVENTS

Multifocal IOL implants may be inadvisable in patients with conditions such as macular degeneration, retinal pigment epithelium changes, and glaucoma. In rare cases, severe incidents of halos and/or glare may result in the multifocal IOL being explanted and replaced with another type of IOL.

INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR TECNIS SYMFONY AND TECNIS SYMFONY TORIC EXTENDED RANGE OF VISION IOLs

CAUTION:

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

INDICATIONS FOR USE:

The TECNIS Symfony Extended Range of Vision IOL, Model ZXR00, is indicated for primary implantation for the visual correction of aphakia, in adult patients with less than 1 diopter of pre-existing corneal astigmatism, in whom a cataractous lens has been removed. The lens mitigates the effects of presbyopia by providing an extended depth of focus. Compared to an aspheric monofocal IOL, the lens provides improved intermediate and near visual acuity, while maintaining comparable distance visual acuity. The Model ZXR00 IOL is intended for capsular bag placement only.

The TECNIS Symfony Toric Extended Range of Vision IOLs, Models ZXT150, ZXT225, ZXT300, and ZXT375, are indicated for primary implantation for the visual correction of aphakia and for reduction of residual refractive astigmatism in adult patients with greater than or equal to 1 diopter of preoperative corneal astigmatism, in whom a cataractous lens has been removed. The lens mitigates the effects of presbyopia by providing an extended depth of focus. Compared to an aspheric monofocal IOL, the lens provides improved intermediate and near visual acuity, while maintaining comparable distance visual acuity. The Model Series ZXT IOLs are intended for capsular bag placement only.

CONTRAINDICATIONS:

None.

RISKS:

Routine cataract surgery risks, irrelevant to lens selection, could be minor, temporary, or affect patients’ vision permanently. Rare complications are worsening of vision, bleeding, or infection. Risks related to use of this lens include a slight loss in vision sharpness with decreased use of glasses. Even with glasses, loss of sharpness may worsen under poor visibility conditions such as dim light or fog. This may lead to driving difficulties, and not detecting road hazards as quickly at night or in fog. Patients may also notice halos, starbursts, glare, and other visual symptoms with extended range of vision IOLs. This may impact patients when there are bright lights at night. Patients should discuss all risks and benefits with their eye doctor before surgery.

WARNINGS:

A small number of patients may want their Tecnis Symfony IOL removed because of lens-related optical/visual symptoms. Patients with pre-existing diseases or conditions (i.e., diabetes and heart disease) may have higher risk of experiencing complications (e.g., more difficult recovery) after routine cataract surgery. Patients should not receive this lens if they have had previous trauma to their eye. Not evaluated for use in children.

PRECAUTIONS:

If the patient’s eye is unhealthy (including glaucoma), vision may not be good even after cataract removal; patients may not get full benefit of the Tecnis Symfony IOL. Before surgery, the eye doctor will check for any eye diseases. Patients’ vision with the IOL may not be good enough to perform detailed ‘up-close’ work without glasses, and rarely, may make some types of retinal treatment (e.g., retinal tear repair) more difficult. Patients should take all prescribed medicines and apply eye drops as instructed to avoid inflammation and infection. Patients should avoid bending down and playing sports, which can harm the eye during recovery. The eye doctor will tell patients what activities to avoid.

ATTENTION

Reference the Directions for Use for a complete listing of Indications and Important Safety Information.

INDICATIONS AND IMPORTANT SAFETY INFORMATION for the CATALYS^® Precision Laser System

CAUTION

Federal law (USA) restricts this device to sale by or on the order of a physician. The system should be used only by qualified physicians who have extensive knowledge of the use of this device and have been trained and certified.

ATTENTION

Reference the labeling for a complete listing of Important Indications and Safety Information.

INDICATIONS

The OptiMedica Catalys Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, phacofragmentation, and the creation of single plane and multi-plane arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure.

CONTRAINDICATIONS

The CATALYS System should not be used if you are not a candidate for cataract surgery, have certain pre-existing corneal problems or eye implants; or if you are younger than 22 years of age. Tell your doctor about any eye-related conditions, injuries, or surgeries.

PRECAUTIONS

Patients must be able to lie flat on their backs and motionless during the procedure. Patients must be able to tolerate local or topical anesthesia. Tell your doctor if you are taking any medications such as alpha blockers (like Flomax^® to treat an enlarged prostate) as these medications may affect how the doctor does the cataract surgery.

ADVERSE EFFECTS

Complications associated with the CATALYS System include mild broken blood vessels or redness on the white part of your eye, which may last for a few weeks. Other potential risks associated with cataract surgery may occur. These risks may include but are not limited to corneal swelling and/or abrasion, lens capsular tear, infection, inflammation, eye discomfort, and reduced vision. Talk to your doctor regarding all the potential risks associated with these procedures.

INDICATIONS and IMPORTANT SAFETY INFORMATION for TECNIS Eyhance^™ and TECNIS Eyhance^™ Toric II IOLs with TECNIS Simplicity^® Delivery System

INDICATIONS FOR USE:

The TECNIS Simplicity^® Delivery System is used to fold and assist in inserting the TECNIS Eyhance^™ IOL for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag.

The TECNIS Simplicity^® Delivery System is used to fold and assist in inserting the TECNIS Eyhance^™ Toric II IOLs for the visual correction of aphakia and pre-existing corneal astigmatism of one diopter or greater in adult patients with or without presbyopia in whom a cataractous lens has been removed by phacoemulsification and who desire reduction in residual refractive cylinder. The lens is intended to be placed in the capsular bag.

CONTRAINDICATIONS:

There are no known conditions under which the TECNIS Eyhance^™ and TECNIS Eyhance^™ Toric II IOLs should not be used.

RISKS:

There are risks to routine cataract surgery. This is irrelevant to the lens you choose. The problems could be minor, temporary, or affect your vision permanently. Complications are rare. These may include worsening of your vision, bleeding, or infection. Similar to other monofocal IOLs, patients implanted with the TECNIS Eyhance^™ or TECNIS Eyhance^™ Toric II IOLs may require glasses for some tasks. Discuss all risks and benefits with your eye doctor prior to surgery.

WARNINGS:

Pre-existing diseases or conditions may place you at higher risk of experiencing complications (e.g., more difficult recovery) after routine cataract surgery. Examples of pre-existing diseases or conditions include, but are not limited to: ocular inflammation, surgical difficulties at the time of cataract extraction, suspected eye infection, congenital bilateral cataract, history or predisposition to retinal detachment, patients with only one good eye with potentially good vision, medically uncontrollable glaucoma, diabetes, heart disease, and previous trauma to your eye. The TECNIS Eyhance^™ Toric II IOL corrects astigmatism when it is placed correctly in the eye. There is a chance that the TECNIS Eyhance^™ Toric II IOL could be placed incorrectly or could move within the eye, resulting in visual distortions. A second surgery may be needed to properly position the lens. These lenses have not been evaluated for use in children.

PRECAUTIONS:

The effects of the TECNIS Eyhance™ and TECNIS Eyhance™ Toric II IOL optical design on quality of vision, contrast sensitivity, and subjective visual disturbances (glare, halo, etc.) have not been evaluated clinically. If your eye is not healthy (including glaucoma), your vision may not be good even after your cataract is removed. In this case, you may not get the full benefit of the TECNIS Eyhance^™ and TECNIS Eyhance^™ Toric II IOLs. Before surgery, your eye doctor will check if you have any eye diseases that may influence your IOL selection. In rare instances, the TECNIS Eyhance^™ and TECNIS Eyhance^™ Toric II IOLs may make some types of retinal treatment (e.g., retinal tear repair) more difficult. Take all prescribed medicines and apply eye drops as instructed to avoid inflammation and infection. Your eye doctor may tell you if you should avoid certain activities after surgery.

SIDE EFFECTS:

Side effects of cataract surgery with the TECNIS Eyhance^™ and TECNIS Eyhance^™ Toric II IOLs may include swelling/thickening of an area of the retina, and/or the need for a second surgery to reposition the lens, repair the retina, or remove the new lens.

ATTENTION

Reference the Directions for Use for a complete listing of Indications and Important Safety Information.

INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR TECNIS SYNERGY^™ AND TECNIS SYNERGY^™ TORIC II IOL WITH TECNIS SIMPLICITY^® DELIVERY SYSTEM, MODELS DFR00V AND DFW

CAUTION:

Federal law restricts this device to sale, distribution and use by or on the order of a physician.

INDICATIONS FOR USE:

The TECNIS Simplicity^® Delivery System is used to fold and assist in inserting the TECNIS Synergy^™ IOL, which is indicated for primary implantation for the visual correction of aphakia in adult patients, with less than 1 diopter of pre-existing corneal astigmatism, in whom a cataractous lens has been removed. The TECNIS Simplicity^® Delivery System is used to fold and assist in inserting the TECNIS Synergy^™ Toric II IOLs, which are indicated for primary implantation for the visual correction of aphakia and for reduction of refractive astigmatism in adult patients, with greater than or equal to 1 diopter of preoperative corneal astigmatism, in whom a cataractous lens has been removed. Compared to an aspheric monofocal lens, the TECNIS Synergy^™ IOLs mitigate the effects of presbyopia by providing improved visual acuity at intermediate and near distances to reduce eyeglass wear, while maintaining comparable distance visual acuity. The lens is intended for capsular bag placement only.

CONTRAINDICATIONS:

None.

RISKS:

Routine cataract surgery risk, irrespective of lens selection, could be minor, temporary, or affect patients’ vision permanently. Rare complications are worsening of vision, bleeding, or infection. Risks related to use of this lens include halo or glare in nighttime or poor visibility conditions. These may be perceived as an annoyance or hindrance, which, on rare occasions, may be significant enough for the patient to request removal of the IOL. Patients should discuss all risks and benefits with their eye doctor before surgery.

PRECAUTIONS:

Recent contact lens usage may affect the patient’s refraction; therefore, in contact lens wearers, surgeons should establish corneal stability without contact lenses prior to determining IOL power. Prior to surgery, the surgeon must inform prospective patients of the possible risks and benefits associated with the use of this device and provide a copy of the patient information brochure to the patient. Patients with a predicted postoperative astigmatism greater than 1.0 D may not be suitable candidates for implantation with the TECNIS Synergy™ and TECNIS Synergy™ Toric IOLs, as they may not obtain the benefits of reduced spectacle wear or improved intermediate and near vision seen in patients with lower postoperative astigmatism. The safety and effectiveness of the TECNIS Synergy™ IOL have not been substantiated in patients under the age of 22 or those with preexisting ocular conditions and intraoperative complications.

WARNINGS:

Physicians considering lens implantation should weigh the potential risk/benefit ratio. Well-informed patients with well-defined visual needs and preferences should be selected for lens implantation. Patients should be informed of the possibility of visual effects (such as halo or glare around lights), which may be expected in nighttime or poor visibility conditions.

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