On August 29, 2018, 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. This action was based on an analysis of five-year post-surgery data from the FDA-mandated post-approval safety study.
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. The communication, based on preliminary review of longer-term data from an ongoing FDA-mandated post-approval study, cited concerns regarding significant endothelial cell loss and reductions in endothelial cell density (ECD), and provided preliminary recommendations. Since then, the FDA has received additional post-approval study data that confirm the recommendations made in September. Our review also supports the three new recommendations to eye care providers that we are adding in this update. Key findings from our review include: