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FDAAugust 28, 2018device

CyPass System 241, Intraocular Pressure Lowering Implant, CYPASS MICRO-STENT, CYPASS APPLIER, REF: 8065754001. For ophthalmic use.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Analysis of the completed dataset from the COMPASS-XT long-term study showed that the CyPass Micro-Stent group experienced statistically significant endothelial cell loss (ECL) compared to the group who underwent cataract surgery alone.

What to do

FDA enforcement status: Terminated

Brands named

alcon researchalcon

UPCs

0038065754001300806575400132038065754001710380657540010

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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