FDA has issued a safety alert on Alcon’s CyPass Micro-Stent, a small tube with tiny holes that is surgically implanted in the eye, due to its risk of eye damage. The device is used to drain fluid that causes high eye pressure and vision loss in people with glaucoma. In 2016, the device was approved for use during cataract surgery to reduce eye pressure in adults with the most common type of glaucoma, open-angle glaucoma.
An FDA notice says that patients who have the device implanted are at risk of losing cells in the protective outer layer of the eye (cornea). “Endothelial cells line the inner surface of the eye's cornea and are important in keeping vision clear,” it says. “These cells do not regrow after they are damaged. Endothelial cell loss may be associated with damage to the cornea including swelling, cloudiness, eye pain, reduction in vision, and the potential need for corneal transplant.”
Based on information from a post-approval study required by FDA, Alcon is collecting all unused devices (voluntary market withdrawal) and is asking physicians to stop implanting the device.