CyPass Micro-Stent Lawsuit
On August 29, 2018, Alcon, through its parent company Novartis, announced a voluntary global market withdrawal of its eye stent. Alcon instructed ophthalmic surgeons to cease further implantation of the CyPass Micro-Stent. Physicians were instructed to return any unused eye stents to the company.
What is the CyPass Micro-Stent?
The CyPass Micro-Stent is a tiny tube with small holes used during glaucoma surgery. The medical device is implanted in the eye during the surgical procedure to help reduce pressure in the eye. By reducing pressure in the eye, the eye stent helps prevent the progression of glaucoma and further vision loss. However, further study reveals the eye stent could result in serious complications.
FDA Issues a Class 1 Recall of Alcon CyPass Micro-Stent Systems
The CyPass Micro-Stent System manufactured by Alcon Research, LTD is subject to a Class 1 recall by the Food and Drug Administration (FDA). This recall is the most serious type of recall by the FDA because the use of this medical device could result in serious injuries or death. The FDA initially issued a Safety Communication on September 14, 2018 warning of the dangers associated with the eye stent. Approximately one month later, the FDA issued the Class 1 recall.
What is the Problem with the CyPass Micro-Stent?
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.
Complications From Use of the CyPass Micro-Stent
Potential complications associated with the use of the CyPass Micro-Stent include:
- Loss of vision
- Damage to the cornea
- General eye damage
- Eye pain
- Cloudy vision
- Eye swelling
- Progression of glaucoma
- Corneal transplants
- CyPass Micro-Stent removal surgery
Patients who had the eye stent implanted after surgery should immediately contact their physician to discuss any concerns, symptoms, or complications.
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