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U.S. Department of Health and Human Services

Medical Devices

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XACT® Soft Acrylic UV Light-Absorbing Posterior Chamber Intraocular Lens - P080021

photo of XACT® Soft Acrylic UV Light-Absorbing Posterior Chamber Intraocular Lens - P080021This 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: The Advanced Vision Science (AVS), Inc. XACT® Foldable Hydrophobic Acrylic Ultraviolet (UV) Light-Absorbing Posterior Chamber Intraocular Lens
PMA Applicant: Advanced Vision Science (AVS), Inc.
Address: 5743 Thornwood Drive, Goleta, CA 93117
Approval Date: February 2, 2009
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf8/P080021a.pdf

What is it? The AVS, Inc. XACT ® Foldable Hydrophobic Acrylic UV Light-Absorbing Posterior Chamber IOL is plastic lens used to replace the natural lens after it is removed during cataract surgery to restore vision. 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 AVS, Inc. XACT® Foldable Hydrophobic Acrylic UV Light-Absorbing Posterior Chamber IOL correctly focuses light on the retina to restore vision.

When is it used? The AVS, Inc. XACT® Foldable Hydrophobic Acrylic UV Light-Absorbing Posterior Chamber IOL is used to restore vision in adult patients who have had a cataract removed.

What will it accomplish? The AVS, Inc. XACT® Foldable Hydrophobic Acrylic UV Light-Absorbing Posterior Chamber IOL acts as a substitute for the removed natural lens to restore vision.

Additional information: The Summary of Safety and Effectiveness and Labeling will be available online.