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New Device Approval

VISTAKON® (senofilcon A) Contact Lens - P040045

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: VISTAKON® (senofilcon A) Contact Lens
Manufacturer: VISTAKON®, Division of Johnson& Johnson Vision Care, Inc.
Address: 7500 Centurion Parkway, Suite 100, Jacksonville, FL 32256
Approval Date: December 20, 2005
Approval Letter: http://www.fda.gov/cdrh/pdf4/p040045a.pdf

What is it? VISTAKON® (senofilcon A) is a soft contact lens made of approximately 38% water and 62% senofilcon A (a silicone-containing hydrogel). It is available in spherical, toric, multifocal, and multifocal-toric designs.

How does it work? When placed on the eye, the lens focuses light onto the retina (the light sensitive area in the back of the eye). The lens material permits a high level of oxygen to reach the eye, which helps to maintain the eye’s natural function during wear.

When is it used? The lens is used for daily wear during waking hours. It may also be worn for extended periods of from 1 to 7 days, between removals for cleaning and disinfection.

What will it accomplish? The lens corrects conditions in which the eye does not focus properly (refractive error), such as near-sightedness (myopia), far-sightedness (hyperopia), astigmatism, and long-sightedness or impaired vision accompanying advancing years (presbyopia).

Additional information: The Summary of Safety and Effectiveness and labeling is available at: http://www.fda.gov/cdrh/pdf4/p040045.html

Other:

Updated January 19, 2006

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