Class 2 Device Recall Alcon CustomPak, Surgical Procedure Pack

• Date Initiated by Firm: September 07, 2023
• Date Posted: November 07, 2023
• Recall Status: Open, Classified
• Recall Number: Z-0260-2024
• Recall Event ID: 93115
• 510(K)Number: K880961
• Product Classification: General surgery tray - Product Code LRO
• Product: Alcon Custom-Pak, Surgical Procedure Pack REF 14057-09, 45K W/DUOVISC CATARACT, N VIRGINIA EYE SURG CTR
• Code Information: LOT # : 160NMU, UDI: (01)10380653302278
• FEI Number: 1000117501
• Recalling Firm/ Manufacturer: Alcon Research, LLC; 9965 Buffalo Speedway; Houston TX 77054-1309
• For Additional Information Contact: Kristen Kellerhals; 713-668-9100
• Manufacturer Reason for Recall: Custom surgical procedure packs contain latex gloves but are labeled as "latex free".
• FDA Determined Cause: Nonconforming Material/Component
• 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.
• Quantity in Commerce: 120 packs
• Distribution: US: VA OUS: None
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = LRO