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FDAAugust 28, 2018device

CyPass System 241-S, CYPASS MICRO-STENT, CYPASS LOADED, CYPASS APPLIER, REF CATALOG #: 8065754003 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

00380657540037

Recall history

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

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