FDA Recalls Acon’s CyPass Micro-Stent For Glaucoma Patients
The FDA has recalled the CyPass Micro-Stent manufactured by Acon for glaucoma treatment. The CyPass stent is only one of four minimally invasive procedures to treat the eye disorder. Yet, after five years individuals have a greater risk of corneal loss.
About CyPass Micro-Stent
The FDA approved Acon’s CyPass Micro-Stent in July 2016. The stent is for use in conjunction with cataract surgery in adult patients with mild-to-moderate primary open-angle glaucoma. The FDA granted approval based on the device reducing eye pressure in adults with open-angle glaucoma.
Device approval was based on a randomized controlled clinical study. Patients who received the device after cataract surgery were compared to a set of patients who had cataract surgery without the device. At the time of approval, patients had been followed for two years and results showed that there was no clinically significant difference in corneal cell loss between the two groups. However, after two years the data dramatically changed.
CyPass Micro-Stent Recall
The FDA noticed that after five years, patients expressed a dramatic increase in corneal cell loss as compared to those who did not receive it. Endothelial cells line the inner surface of the eye’s cornea and are important in keeping vision clear. The body does not regrow damaged cells. Symptoms of endothelial cell loss and cornea damage include swelling, cloudiness, eye pain, reduction in vision. Also, people may need a corneal transplant.
As a result of these post-approval study findings, Alcon and the FDA announced a voluntary market withdrawal of the device. Also, both are asking physicians to stop implantation immediately.
Anyone who had the Alcon CyPass Micro-Stent placed in their eye and lost his or her cornea, should contact us immediately. We have over 20 years of experience representing injured victims from medical devices. Our consultations are completely free and confidential. Let our experience get you the justice you deserve.