Alcon, a subsidiary of Novartis that focuses on manufacturing eye-care products, withdrew its CyPass Micro-Stent from the global market after a long-term safety study. The devicemaker also advised surgeons to immediately stop using the product.
Here are five things to know:
1. The CyPass Micro-Stent was approved by the FDA in 2016 to use with cataract surgery in adults with glaucoma.
2. A long-term safety study revealed that five years post-surgery, patients with implanted CyPass Micro-Stents experienced statistically significant endothelial cell loss compared to the group who underwent cataract surgery alone.
3. The voluntary recall applies to all versions of the CyPass Micro-Stent.
4. "We believe that withdrawing the CyPass Micro-Stent from the market is in patients' best interest and is the right thing to do,” said Stephen Lane, MD, CMO of Alcon.
5. Alcon is contacting surgeons with recommendations for evaluating and managing the patients who have already received the stent.