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U.S. Department of Health and Human Services

Class 2 Device Recall eyepak Tray Support Cover

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  Class 2 Device Recall eyepak Tray Support Cover see related information
Date Initiated by Firm June 03, 2014
Date Posted September 24, 2014
Recall Status1 Terminated 3 on July 27, 2015
Recall Number Z-2694-2014
Recall Event ID 68487
Product Classification Drape, patient, ophthalmic - Product Code HMT
Product eye-pak 7407 Tray Support Cover REF 8065740745
Code Information Item Number 8065740745 with Lot numbers 613207-07V, 613221-07V, 613228-07V, 613249-07V, 613256-07V, 35206V, and 352699V.
Recalling Firm/
Alcon Research, Ltd.
6201 South Fwy
Fort Worth TX 76134-2099
For Additional Information Contact
Manufacturer Reason
for Recall
The peel pouches of the Tray Support Covers may be insufficiently sealed so that sterility cannot be assured.
FDA Determined
Cause 2
Packaging process control
Action Alcon Research sent an Urgent Medical Device Recall letter dated June 3, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Please follow these important steps: 1) Review your inventory of Tray Support Covers to determine if you have any units from the affected Lots in stock. 2) Place the product aside to ensure it is not used. 3) Return the attached Response Form via fax or email to Alcon. Please return the Response Form even if you do not have any inventory from the affected lots. 4) Alcon will contact you to arrange the return of your inventory. If you have any further questions, concerns, or need assistance with obtaining replacement product, please contact Alcon Customer Service at 1-800-862-5266.
Quantity in Commerce 2462
Distribution Worldwide Distribution - Nationwide Distribution and the countries of Australia, Belgium, and Canada.
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.