FDA Safety Communication about Potential Eye Damage from Alcon CyPass Micro-Stent

PUBLISHED: Sep 17, 2018
Relevant to: Ambulatory Care, Critical Access Hospitals, Hospitals, Medical Office

The U.S. Food and Drug Administration (FDA) has issued a safety communication about potential eye damage from Alcon CyPass Micro-Stents, a small tube with tiny holes that is surgically implanted in the eye. The device is used to drain fluid that causes high eye pressure and vision loss in people with glaucoma. In 2016, the device was approved by the U.S. Food and Drug Administration (FDA) for use during cataract surgery to reduce eye pressure in adults with open-angle glaucoma.

According the FDA’s Safety Communication, people who have the CyPass device implanted are at risk of losing cells in the cornea. Endothelial cells line the inner surface of the eye's cornea and are important in keeping vision clear. These cells do not regrow after they are damaged. Endothelial cell loss may be associated with damage to the cornea including swelling, cloudiness, eye pain, reduction in vision, and the potential need for corneal transplant.

The FDA’s initial review of five-year data for patients from the required post-approval study shows a concerning difference in the degree of corneal cell loss in patients who received the CyPass device compared to those who did not receive it. At five years, patients who have the device had less endothelial cell density than the control group. In addition, the preliminary review shows that significantly more patients who received the device had a reduction in endothelial cell density at five years compared to the control group.

As a result of these post-approval study findings, Alcon announced a voluntary market withdrawal of the device and is asking physicians to stop implantation immediately.

Recommendations for Eye Care Providers:

  • Do not implant CyPass Micro-Stents and return unused devices to Alcon. Call Alcon at 1-800-862-5266 for directions on how to return the device.
  • Review Alcon's recommendations for evaluating and managing CyPass Micro-Stents in patients who have already received the device, such as repositioning or trimming.
  • At the current time it is not known how endothelial cell density loss might continue to progress more than five years after the original surgery, and what impact surgery to remove the device may have on further endothelial cell density loss.

Patients who have the CyPass Micro-Stent implanted, should be advised to make an appointment with their eye care provider as soon as possible to determine what action to take.

See the FDA Safety Communication, link below, for additional information.

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