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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 August 08, 2017
Date Posted August 25, 2017
Recall Status1 Terminated 3 on August 05, 2019
Recall Number Z-0053-2018
Recall Event ID 77965
510(K)Number K880961  
Product Classification General surgery tray - Product Code LRO
Product Alcon Custom Pak
Code Information 2033459H, 2034186H, 2034491H
Recalling Firm/
Manufacturer		 Alcon Research, LTD.
9965 Buffalo Speedway
Houston TX 77054-1309
For Additional Information Contact Bill Walker
800-862-5266
Manufacturer Reason
for Recall		 Alcon is initiating a medical device recall, after receiving notification from a supplier of a recall for x-ray detectable sponges. The one product referenced in the supplier recall notification, is used within Alcon Custom Paks.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action The medical user was sent a customer recall notification letter on 8/7/17. The medical user is requested to return the unused, affected Custom Paks to Alcon. Upon receipt and verification, Alcon will destroy the affected sponges in a controlled manner via physical destruction.
Quantity in Commerce 33 units
Distribution States in the US - WI, NY, MO
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
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