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

Recall Z-2066-2017 — Healon Pro, Part No. 10270012

U.S. FDA — Device Enforcement · United States · 2017-04-01 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2066-2017
Date of alert
2017-04-01
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Abbott Medical Optics Inc. (AMO)
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10270012
Reported risk: Remote possibility that certain solutions in these lots may contain microscopic glass particles due to damage that occurred at the cylinder neck during the manufacturing process.
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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