Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0185-2019 — CyPass System 241-S, CYPASS MICRO-STENT, CYPASS LOADED, CYPASS APPLIER, REF CATALOG #: 8065754003 For ophthalmic use.

U.S. FDA — Device Enforcement · United States · 2018-08-28 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0185-2019
Date of alert
2018-08-28
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Alcon Research, LTD.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00380657540037
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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