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: Endocapsular Tension Ring, Types 14, 14A and 14C
Manufacturer: Morcher GmbH
Address: Kapuzinerweg 12, D-70374 Stuttgart, Deutschland BR Germany
Approval Date: October 23, 2003
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf/P010059a.pdf
What is it? The Endocapsular 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 CTR is a plastic ring approximately 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 three sizes of CTRs that allow the surgeon to fit the device to a patient’s eye.
When is it used? The 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 CTR provides support to the capsular bag of the eye while the surgeon inserts and stabilizes an intraocular lens during cataract surgery. The CTR remains in place after surgery.
When should it not be used? The CTR should not be used in patients who:
- have perforated or damaged lens capsules
- are under 12 years of age because the eyes are still growing.
Summary of Safety and Effectiveness and labeling will be available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p010059