UPDATE: Potential Eye Damage from Alcon CyPass Micro-Stent Used to Treat Open-Angle Glaucoma: FDA Safety Communication
24 October 2018
Audience
People who have a CyPass Micro-Stent to treat open-angle glaucoma during cataract surgery
Eye care providers
Medical Specialties
Ophthalmology, Optometry
Device
Alcon’s CyPass Micro-Stent is a small tube with tiny holes that is surgically placed (implanted) in the eye. 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 by the U.S. Food and Drug Administration (FDA) for use during cataract surgery to reduce eye pressure in adults with the most common type of glaucoma, open-angle glaucoma.
Alcon announced an immediate, voluntary market withdrawal of the CyPass Micro-Stent from the global market. In addition, Alcon advised surgeons to immediately cease further implantation with the CyPass Micro-Stent and to return any unused devices to Alcon.
On September 14, 2018, the FDA issued a Safety Communication to alert eye care providers and patients of the risk of damage to the cells lining the cornea of the eye in people who have the CyPass Micro-Stent implanted.
For the full FDA Safety Communication,
