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

Recall Z-0983-2017 — Algerbrush-II Product Usage: Medical - For surgeons to use in ophthalmic surgical procedures to remove foreign bodies from the eye of the patient

U.S. FDA — Device Enforcement · United States · 2016-10-12 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0983-2017
Date of alert
2016-10-12
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Bausch & Lomb, Inc.
Product category
device
Product type
Devices
Reported risk: According to firm ( Bausch & Lomb, Inc. ) on June 17, 2016 a packaging operator notified his supervisor he had not placed the operating instruction into the last repackaging of SKU 0816 C (Pterygium Burr Medium Diamond). Further investigation found that repackaged Algerbrush-II and its accessories from April 30, 2012 to present, contained out of date operating instruction. Therefore Bausch & Lomb is proposing a Field Correction to provide customer purchasing product from April 30, 2012 to June 20, 2016 with the current operating instruction.
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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