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

Recall Z-0961-2019 — Alcon or Endure Ophthalmic Microscope Product Usage: Used for low magnification visualization during ophthalmic surgical procedures for cataract, retina and cornea.

U.S. FDA — Device Enforcement · United States · 2018-07-17 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0961-2019
Date of alert: 2018-07-17
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Alcon Research Laboratories Ltd.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 8065752304

Reported risk: Potential for the optical head to detach from the stand due to the lack of thread adhesive.

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.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Recall Z-0961-2019 — Alcon or Endure Ophthalmic Microscope Product Usage: Used for low magnification visualization during ophthalmic surgical procedures for cataract, retina and cornea.

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