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U.S. Department of Health and Human Services

Medical Devices

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AcrySof® Toric Intraocular Lens - (IOL) - P930014/S045

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: AcrySof® Toric Intraocular Lens Models SN60T6, SN60T7, SN60T8, and SN60T9; and AcrySof® IQ Toric Intraocular Lens Models SN6AT6, SN6AT7, SN6AT8, and SN6AT9
PMA Applicant: Alcon Laboratories, Inc.
Address: 6201 South Freeway, Fort Worth, TX 76134-2099
Approval Date: May 3, 2011
Approval Letter:
http://www.accessdata.fda.gov/cdrh_docs/pdf/p930014s045a.pdf

What is it? The AcrySof® Toric posterior chamber intraocular lens (IOL) is an artificial 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. A version of this lens, the AcrySof® IQ Toric IOL, is manufactured to improve distance vision under low light conditions (aspheric optic design). Clinical studies have not been conducted with the AcrySof® IQ Toric IOL to assess the effect of the added aspheric surface on vision.

How does it work? The AcrySof® Toric IOL acts in place of the healthy eye lens to correctly focus light on the retina and restore vision. The lens of the IOL is convex on both sides (biconvex) and is shaped to provide both spherical and astigmatic correction.

When is it used? The AcrySof® Toric IOL is used to restore vision in adult patients with corneal astigmatism (a football-shaped cornea) who have had a cataract removed. It is intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia in adult patients who have had a cataract removed.

What will it accomplish? The AcrySof® Toric IOL restores vision by acting as a substitute for the removed natural lens.

When should it not be used? The AcrySof® Toric IOL should not be implanted when the IOL may make worse an existing condition, interfere with the diagnosis or the treatment of a condition, or present a risk to the sight of the patient.

Additional information: Summary of Safety and Effectiveness and labeling are available online.

Other Resources:

NIH - MedlinePlus - Cataract