Important Safety Information – TECNIS Multifocal IOL

Indication Statement

TECNIS^® Multifocal 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
As with many things, there may be a trade off. If you decide to have a multifocal lens, your use of glasses may decrease, but at the cost of losing some of the sharpness of your vision. Even with glasses, this loss of sharpness may become worse under poor visibility conditions such as dim light or fog. There may also be some visual side effects such as halos and glare from lights at night that are more common than with a monofocal IOL. Halos are rings of light that you may notice when looking directly at a source of light, such as oncoming car headlights. Glare is a scattered light effect that can appear around a source of light.

General risks with cataract surgery and IOL implantation:

Whatever your lens choice is, there are risks and possible complications of cataract surgery and lens implantation. Complications could be minor or temporary, or could permanently affect your vision. Complications are rare and may include the worsening of your vision, bleeding, or infection. Contact your eye doctor right away if you have any of the following symptoms after surgery: itching, pain, flashing lights/“floaters”/a “curtain” in your vision, redness, severe headache, nausea/vomiting, sensitivity to light or watery eye.

PLEASE NOTE: Warnings and precautions accompany all IOLs because they are prescription-only medical devices. The following warnings and precautions apply to all multifocal IOLs.

Warnings

1. A very small number of patients (less than 1% in U.S. clinical studies) may be dissatisfied and request removal of their multifocal IOL.
2. 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.
   
3. In rare instances, multifocal IOLs may make some types of retinal surgery more difficult.

Precautions

1. 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. Be sure to tell your eye doctor if you have any health conditions that may affect your surgery or vision and provide an updated list of medications to the doctor.
2. 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. The TECNIS^® multifocal IOL is designed for near vision at approximately 13 inches.
3. Take all prescribed medicines and apply eye drops as instructed.
4. You should avoid any activity that could harm your eye while you are recovering from surgery. Before and after the surgery, your eye doctor will tell you about activity restrictions.
5. If you wear contact lenses, your eye doctor may ask you to discontinue wearing your lenses prior to being evaluated for the multifocal IOL.
6. There were no patients 21 years old or younger included in the clinical study. As a result, there are insufficient data to support safety and effectiveness of this IOL in this age group.

Adverse Events

The following adverse events occurred during the clinical trial of the TECNIS Multifocal intraocular lens and are listed in order of frequency:

1. Macular edema occurred at a cumulative rate of 2.6%.
2. Non lens-related secondary surgical intervention due to lens exchange (lens power refractive error and incorrect lens type) occurred at a cumulative rate of 1.2%.
3. Non lens-related secondary surgical intervention due to retinal repair occurred at a cumulative rate of 0.9%.
4. Non lens-related secondary surgical intervention due to treatment for cystoid macular edema occurred at a cumulative rate of 0.6%.
5. Non lens-related secondary surgical intervention due to iris prolapse/wound repair occurred at a cumulative rate of 0.3%.
6. Non lens-related secondary surgical intervention due to trabeculectomy and two subsequent filtration bleb revisions occurred at a cumulative rate of 0.3%.
7. Lens-related secondary surgical intervention due to lens removal (due to halos/glare) occurred at a cumulative rate of 0.3%.
8. Lens-related secondary surgical intervention due to lens repositioning occurred at a cumulative rate of 0.3%.
9. Endophthalmitis occurred at a cumulative rate of 0.3%.
10. Hypopyon occurred at a cumulative rate of 0.3%.