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

Recall Z-1947-2014 — Alcon CUSTOM-PAK containing Anterior Chamber Cannula 27G Component Part Number 585006 contained in Alcon Assembly Numbers 9795-37, 11233-14, and 13334-04. The product is typically inserted through an incision during cataract surgery to deliver balanced salt solution to help anterior chamber spac

U.S. FDA — Device Enforcement · United States · 2014-05-16 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1947-2014
Date of alert: 2014-05-16
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Alcon Research, Ltd.
Product category: device
Product type: Devices

Reported risk: Alcon CUSTOM-PAK which is supposed to contain a 27G Anterior Chamber Cannula (27G x 7/8 in) actually contains a 27G Sharp Tip Needle

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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