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New Device Approval

AcrySof® ReSTOR Apodized Diffractive Posterior Chamber Intraocular Lens (IOL) - P040020

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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 and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.

Product Name: AcrySof® ReSTOR Apodized Diffractive Posterior Chamber Intraocular Lens (IOL)
Applicant: Alcon Research Ltd.
Address: 6201 South Freeway
Fort Worth, TX 76134-2099
Approval Date: March 21, 2005
Approval Letter: http://www.fda.gov/cdrh/pdf4/P040020a.pdf

What is it? The ACRYSOF® ReSTOR® Apodized Diffractive Optic Posterior IOL is an artificial lens implanted in the eye to restore vision after a clouded natural lens (cataract) is removed.

The lens of the IOL is convex on both sides (biconvex) and made of a soft plastic that can be folded prior to insertion, allowing placement through an incision smaller than the optic diameter of the lens. After surgical insertion into the eye, the lens gently unfolds to restore vision. The supporting arms (haptics) provide for proper positioning of the IOL within the eye.

How does it work? The ACRYSOF® ReSTOR® IOL is intended to be positioned in the posterior chamber of the eye, replacing the natural lens. This position allows the IOL to correct the visual impairment of aphakia (absence of the natural lens). The ACRYSOF® ReSTOR® IOL has a biconvex optic that is shaped using a special process called apodized diffraction to provide increased depth of focus.

When is it used? The ACRYSOF® ReSTOR® IOL is used in adult patients with and without presbyopia, who desire near, intermediate and distance vision with increased independence from glasses following cataract surgery.

What will it accomplish? The ACRYSOF® ReSTOR® IOL has been shown in a clinical study to provide good near, intermediate and distance vision with increased independence from glasses in patients who have undergone cataract surgery.

When should it not be used? There are no known contraindications.

Additional information: Summary of Safety and Effectiveness and labeling will be available at: http://www.fda.gov/cdrh/pdf4/p040020.html

Other:

Updated April 18, 2005

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