Eye care providers should periodically evaluate patients implanted with CyPass (Alcon) stent for potential endothelial cell loss, according to advice issued by the FDA. Specifically, the FDA says eye doctors should look at endothelial cell density using specular microscopy until the rate of loss stabilizes.
The stent’s manufacturer voluntarily withdrew the product from the global market in August after it was connected to potential eye damage, according to the FDA. Alcon became aware of the issue when a five-year study’s results showed statistically significant endothelial cell loss in patient’s who received the device, which is implanted during cataract surgery, compared with patients who underwent cataract surgery alone.
“Eye care providers should evaluate all patients with CyPass to assess device positioning by visualization of the number of retention rings visible on the proximal end of the device. Patients with two or more rings visible upon examination should be evaluated for endothelial cell loss as soon as possible,” the FDA’s statement adds. Surgeons have also been advised to discontinue implanting the device and return it to the company.
|FDA. Update: potential eye damage from Alcon CyPass micro-stent used to treat open-angle glaucoma: FDA safety communication. www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm624283.htm. Published October 24, 2018. Accessed October 29, 2018.|