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: C-flex™ intraocular lens model 570C
PMA Applicant: Rayner Surgical Inc.
Address: 6654 Church Street, Los Angeles, CA 90042
Approval Date: May 3, 2007
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf6/p060011a.pdf
What is it? C-flex™ 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? C-flex™ acts as a healthy eye lens to correctly focuses light on the retina and restore vision.
When is it used? C-flex™ is used to restore vision in adult patients who have had a cataractous lens removed.
What will it accomplish? C-flex™ restores vision by acting as a substitute for the removed natural lens
When should it not be used? C-flex™ should not be implanted in patients who:
- Are younger than 21 years
- Have extremely small eyes
- Have chronic or active ocular disease excluding cataracts
- Are pregnant or nursing
Additional information: The Summary of Safety and Effectiveness and labeling are available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p060011