CyPass Micro-Stent Lawsuit

The FDA initially approved the CyPass eye stent in 2016 after Alcon conducted a controlled clinical study. At the time of the FDA approval of the medical device, patients in the clinical study had been monitored for two years. During those two years, there did not appear to be a substantial difference in the loss of corneal cells between the group that had the CyPass Micro-stent implanted after surgery and the group that did not have the eye stent implanted after surgery.

However, the FDA required the manufacturer to conduct a post-approval study because the FDA recognized the possibility for harmful effects appearing more than two years after the eye stent was implanted. The post-approval study monitored patients for five years after surgery. Based on a review of the preliminary results of the post-approval study, the FDA issued the Safety Communication after Alcon announced its voluntary recall. After that, the FDA issued the Class 1 Recall.

The results of the post-approval study indicate that patients with the eye stent demonstrated a statistically and clinically significant increase in eye damage. Patients with the CyPass Micro-stent were at risk of losing endothelial cells. Endothelial cells do not regrow when they are damaged and are crucial for maintaining clear vision.