INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR TECNIS SYMFONY^TM AND TECNIS SYMFONY^TM 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^TM 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 TECNIS Symfony^TM 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. These models of IOLs, ZXR00, ZXT150, ZXT225, ZXT300, and ZXT375, mitigate the effects of presbyopia by providing an extended depth of focus. Compared to an aspheric monofocal IOL, these models of IOLs provide improved intermediate and near visual acuity, while maintaining comparable distance visual acuity. These models of 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^TM 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^TM 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 TECNIS 1-Piece Monofocal IOL

CAUTION

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

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

Side effects of cataract surgery with the TECNIS 1-Piece IOL included a swelling/thickening of an area of the retina and the need for a second surgery to replace, reposition, or remove the new lens or to repair structures of the eye.

ATTENTION

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

INDICATIONS AND IMPORTANT SAFETY INFORMATION for the TECNIS Toric 1-Piece IOL

CAUTION

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

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

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

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. You may experience vision problems or distortions and may require a second surgery to have your doctor correctly reposition the lens.

PRECAUTIONS

If your eye is not healthy (including glaucoma), you may not get the full benefits of the TECNIS Toric IOL. There is a chance that you still may need glasses for distance vision with a Toric IOL.

SIDE EFFECTS

Side effects of cataract surgery with the TECNIS Toric 1-Piece IOL include the need for a second surgery to reposition the lens or repair the retina, swelling/thickening of the retina and separation of the retina from the surrounding tissues.

ATTENTION

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

INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR THE TECNIS MULTIFOCAL Family of 1-Piece IOLs

CAUTION

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

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

Whereas your use of glasses may decrease, it may come at the cost of some sharpness of your vision. You may also notice more halos (rings of light around a light source) or glare (scattered light effect around a light source). Call your eye doctor right away if you experience any itching, pain, flashing lights, “floaters”, redness, severe headache, nausea/vomitting, light sensitivity, or watery eyes after surgery.

WARNINGS

Less than 1% of patients may not be satisfied and request to remove the IOL. Children under the age of 2 those with previous trauma to their eye should not receive this device.

PRECAUTIONS

If your eye is not healthy (including glaucoma) you may not get the full benefits of the TECNIS Multifocal IOL. Your vision with a multifocal IOL may not be good enough to perform very near or detailed “up-close” work without glasses.

SIDE EFFECTS<

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.

ATTENTION

Please see Directions for Use for a complete list 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 EFFECT

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, reduced vision. Talk to your doctor regarding all the potential risks associated with these procedures.