Food and Drug Recall.org

Reflecting its uncompromising commitment to patient safety, Alcon today announced an immediate, voluntary market withdrawal of the CyPass Micro-Stent from the global market. In addition, Alcon advises surgeons to immediately cease further implantation with the CyPass Micro-Stent and to return any unused devices to Alcon. This decision and corresponding recommendation is based on an analysis of five-year post-surgery data from the COMPASS-XT long-term safety study.
The US Food and Drug Administration (FDA) approved the CyPass Micro-Stent in July 2016 for use in conjunction with cataract surgery in adult patients with mild-to-moderate primary open-angle glaucoma based on the results of the landmark two-year COMPASS study. The COMPASS study demonstrated a statistically significant reduction in intraocular pressure at two years post-surgery in subjects implanted with the CyPass Micro-Stent at the time of cataract surgery, as compared to subjects undergoing cataract surgery alone. At two years post-surgery, there was little difference in endothelial cell loss between the CyPass Micro-Stent and cataract surgery-only groups, and results were consistent with peer-review literature benchmarks of cataract-related endothelial cell loss.1, 2