INDICATIONS AND IMPORTANT SAFETY INFORMATION

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

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 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.