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Open, Classified

Alcon Custom-Pak, Surgical Procedure Pack REF 14057-09, 45K W/DUOVISC CATARACT, N VIRGINIA EYE SURG CTR

FDA Recall Z-0260-2024 · Posted 2023-11-07

Recalling FirmAlcon Research, LLC
Recall StatusOpen, Classified
Product CodeLRO
Date Initiated2023-09-07
Product Quantity120 packs

Reason for Recall

Custom surgical procedure packs contain latex gloves but are labeled as "latex free".

Firm Action

On September 7, 2023, Alcon contacted consignees by phone to notify them of the recall. Alcon asked consignees to take the following action: 1. Discontinue using the affected lot and requested the customer confirm any quantity of remaining units in order to start the return process for any unused custom paks.

Root Cause

Nonconforming Material/Component

Distribution Pattern

US: VA OUS: None

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K880961ALCON SURGICAL PROCEDURE PACKSAlcon Laboratories · 1988-04-29

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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