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FDA Updates Warning on Withdrawn Alcon Device

The product was withdrawn from the market.

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The U.S. Food and Drug Administration has issued new recommendations related to Alcon’s CyPass Micro-Stent, which was in August withdrawn from the global market.

At the time, the company advised surgeons to immediately cease further implantation with the CyPass Micro-Stent and to return any unused devices. The recommendation is based on an analysis of five-year post-surgery data from the COMPASS-XT long-term safety study.

Clinical data “showed it may damage the eye,” Reuters reported.

These are the FDA’s recommendations:

Eyecare 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.
  • All patients that have the CyPass device should be evaluated periodically for endothelial cell density using specular microscopy until the rate of loss stabilizes.
  • Eyecare 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.

Patients

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  • If you have a CyPass Micro-Stent implanted, you should make an appointment with your eye care provider as soon as possible. Your eye care provider will explain your options and help you decide what to do.

The U.S. Food and Drug Administration approved the CyPass Micro-Stent in July 2016 for use in conjunction with cataract surgery in adult patients with mild-to-moderate primary open-angle glaucoma. The approval was based on the results of the two-year COMPASS study.

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