FDA Medical Device Recalls (openFDA)
Alcon Research, Ltd.: eye-pak 7407 Tray Support Cover REF 8065740745
- Recall number
- Z-2694-2014
- Recalling firm
- Alcon Research, Ltd.
- Product
- eye-pak 7407 Tray Support Cover REF 8065740745
- Status
- Terminated
- Initiated
- 2014-06-03
- Posted
- 2014-09-24
- Terminated
- 2015-07-27
- Reason
- The peel pouches of the Tray Support Covers may be insufficiently sealed so that sterility cannot be assured.
- Root cause
- 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
- 2462
- Distribution
- Worldwide Distribution - Nationwide Distribution and the countries of Australia, Belgium, and Canada.
- Lot, serial or model codes
- Item Number 8065740745 with Lot numbers 613207-07V, 613221-07V, 613228-07V, 613249-07V, 613256-07V, 35206V, and 352699V.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HMT
- Firm FEI
- 1610287
- Firm city
- Fort Worth
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28