This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: Tecnis® Multifocal Posterior Chamber Intraocular Lens, Models ZM900 (silicone) and ZMA00 (acrylic)
PMA Applicant: Advanced Medical Optics, Inc.
Address: 1700 E. St. Andrew Place, Santa Ana, CA 92705
Approval Date: January 16, 2009
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf8/P080010a.pdf
What is it? The TECNIS® Multifocal Foldable Intraocular Lens is a plastic lens used to restore vision and replace the natural lens of the eye after it is removed during cataract surgery. A cataract is a gradual thickening, hardening and clouding of the eye's lens, resulting in loss of vision. Cataracts are often the result of aging, but can have other causes.
How does it work? The TECNIS® Multifocal Foldable Intraocular Lens focuses light on the retina and can restore distance, intermediate, and near vision after cataract removal.
When is it used? The TECNIS® Multifocal Foldable Intraocular Lens is used to restore vision in adult patients who have had a cataractous lens removed.
What will it accomplish? The TECNIS® Multifocal Foldable Intraocular Lens decreases the need for glasses (both for distance and near tasks), but at the cost of losing some of the sharpness of vision and the possibility of visual side effects such as halos and glare from lights at night that are more common than with a monofocal IOL.
Additional information: The Summary of Safety and Effectiveness and Labeling is available online.