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U.S. Department of Health and Human Services

Class 2 Device Recall Alcon Surgical Procedure Packs

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  Class 2 Device Recall Alcon Surgical Procedure Packs see related information
Date Initiated by Firm September 21, 2015
Date Posted October 30, 2015
Recall Status1 Terminated 3 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/
Alcon Research, Ltd.
6201 South Fwy
Fort Worth TX 76134-2099
For Additional Information Contact Customer Service
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 2
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 and Original Applicant = ALCON LABORATORIES