FDA Safety Communication - Potential Eye Damage from Alcon CyPass Micro-Stent Used to Treat Open-Angle Glaucoma – Update

PUBLISHED: Oct 25, 2018
Relevant to: Ambulatory Care, Critical Access Hospitals, Hospitals, Long Term Care, Medical Office

The U.S. Food and Drug Administration (FDA) is providing additional information regarding corneal endothelial cell loss in patients who have received the Alcon CyPass Micro-Stent. This safety communication also contains updated recommendations to clinicians who care for patients implanted with the device as well as information related to its recall.

Alcon's CyPass Micro-Stent is a small tube with tiny holes that is 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 the most common type of glaucoma, open-angle glaucoma.

Summary of Problem:

On August 29, 2018, Alcon announced an immediate, voluntary market withdrawal of the CyPass Micro-Stent from the global market. In addition, Alcon advised surgeons to immediately cease further implantation with the CyPass Micro-Stent and to return any unused devices to Alcon. This action was based on an analysis of five-year post-surgery data from the FDA-mandated post-approval safety study.

On September 14, 2018, the FDA issued a Safety Communication to alert eye care providers and patients of the risk of damage to the cells lining the cornea of the eye in people who have the CyPass Micro-Stent implanted. The communication, based on preliminary review of longer-term data from an ongoing FDA-mandated post-approval study, cited concerns regarding significant endothelial cell loss and reductions in endothelial cell density (ECD), and provided preliminary recommendations. Since then, the FDA has received additional post-approval study data that confirm the recommendations made in September. The FDA’s review of study data supports three new recommendations to eye care providers.

Recommendations:

  • 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.
  • All patients that have the CyPass device should be evaluated periodically for endothelial cell density using specular microscopy until the rate of loss stabilizes.
  • Eye care providers should evaluate all patients with CyPass to assess device positioning by visualization of the number of retention rings visible on the proximal end of the device. Patients with two or more rings visible upon examination should be evaluated for endothelial cell loss as soon as possible.
  • Based on the endothelial cell density levels, and other factors such as age and time post-implantation, the surgeon should determine if additional surgical interventions (that is, trimming, repositioning, removal) are appropriate.

Follow the link below for additional information including key findings from the FDA’s review and recommendations for patients.

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