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

Recall Z-1291-2023 — Alcon Custom Pak Surgical Procedure Pack: Pak Number & Pak Description: 17533-04 DR GROSS LPS LLC 18704-03 CATARACT SURGI CARE 18382-03 DR GEORGE ZAMBELLI BEAVER VALLEY ASC 8685-21 CATARACT PACK EYE SURGICAL CNTR OF AR 19451-02 DR ROESKE PACK INLAND VALLEY SURGERY CTR 19136-03 OCCULOPLASTIC W

U.S. FDA — Device Enforcement · United States · 2023-03-10 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1291-2023
Date of alert: 2023-03-10
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Alcon Research, LLC
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00380655132814

Reported risk: Sterility; Steril surgical procedure packs contain incomplete seals.

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.

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