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: Oculaid™ Capsular Tension Ring / Stableyes™ Capsular Tension Ring
Applicant: Ophtec USA, Inc.
Address: 6421 Congress Avenue, Suite 112, Boca Raton, FL 33487
Approval Date: April 27, 2004
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf3/p030023a.pdf
What is it? The Oculaid™ (Stableyes™) Capsular Tension Ring (CTR) assists the cataract surgeon in placing and centering an intraocular lens. It provides additional support to the capsular bag that surrounds the eye’s lens. Intraocular lenses are artificial lenses implanted to restore clear vision when the clouded natural lens is removed during cataract surgery. The CTR is used for patients who have weakened or missing zonules (thin tissue fibers that hold the lens in place) supporting the capsular bag of the eye. Click here to see an illustration of the eye with a cataract: http://www.nlm.nih.gov/medlineplus/ency/presentations/100079_2.htm
How does it work? The Oculaid™ (Stableyes™) CTR is a plastic ring approximately 0.15 - 0.2mm thick. The device is circular except where it is interrupted by a gap with a positioning hole on either side. These holes allow the implanting surgeon to properly position the device in the eye. There are two sizes of CTRs that allow the surgeon to fit the device to a patient’s eye.
When is it used? The Oculaid™ (Stableyes™) CTR is used in adult patients who:
- Are undergoing cataract surgery
- Have weak or partially absent zonules supporting the capsular bag of the eye
Zonular weakness or absence can be caused by:
- Eye trauma
What will it accomplish? The Oculaid™ (Stableyes™) CTR provides support to the capsular bag of the eye while the surgeon inserts and stabilizes an intraocular lens during cataract surgery. The ring remains in place after surgery.
When should it not be used? The Oculaid™ (Stableyes™) CTR should not be used in patients who:
- have torn or compromised lens capsular bags that would fail to provide adequate support for the ring, or perforated or damaged lens capsules
- are under 12 years of age because the eyes are still growing.
Additional information: Summary of Safety and Effectiveness and labeling will be available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p030023