Class 2 Device Recall Alcon Surgical Procedure Packs

• Date Initiated by Firm: September 21, 2015
• Date Posted: October 30, 2015
• Recall Status: Terminated on March 24, 2016
• Recall Number: Z-0195-2016
• Recall Event ID: 72363
• 510(K)Number: K880961
• Product Classification: General surgery tray (kit) - Product Code LRO
• Product: Custom Pak 9319-27. Single-use medical devices and accessories designed by medical professionals for a specific ophthalmic surgical procedure.
• Code Information: 1792733H, 1783925H, 1785227H, 1786729H
• Recalling Firm/ Manufacturer: Alcon Research, Ltd.; 6201 South Fwy; Fort Worth TX 76134-2099
• For Additional Information Contact: Customer Service; 800-862-5266
• Manufacturer Reason for Recall: The recalled lot of custom paks are labeled as latex free and contain latex gloves rather than the specified non-latex gloves.
• FDA Determined Cause: Mixed-up of materials/components
• Action: The recalling firm notified the consignee on 9/21/15 via phone call, and with a follow up visit to the consignee site. The recalled units were recovered.
• Quantity in Commerce: 5 units
• Distribution: Distributed in VT.
• 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

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