Z-2694-2014Class II

eye-pak 7407 Tray Support Cover REF 8065740745

Name: Z-2694-2014 eye-pak 7407 Tray Support Cover REF 8065740745
Creator: Alcon Research, Ltd.
Published: 2014-06-03
License: https://open.fda.gov/license/

Alcon Laboratories / initiated 2014-06-03 / Terminated / root cause: packaging

FDA source

Alcon Research, Ltd. began a recall of eye-pak 7407 Tray Support Cover REF 8065740745 on 2014-06-03. FDA classified it as Class II and gives the reason as "The peel pouches of the Tray Support Covers may be insufficiently sealed so that sterility cannot be assured". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2694-2014
Classification: Class II
Status: Terminated
Initiated: 2014-06-03
Posted: 2014-09-24
Terminated: 2015-07-27
Recalling firm: Alcon Laboratories
Product: eye-pak 7407 Tray Support Cover REF 8065740745
Product code: HMT Drape, Patient, Ophthalmic
Reason for recall: The peel pouches of the Tray Support Covers may be insufficiently sealed so that sterility cannot be assured.
Root cause tag: packaging
FDA 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 in commerce: 2462
Distribution: Worldwide Distribution - Nationwide Distribution and the countries of Australia, Belgium, and Canada.
Product codes and lots: Item Number 8065740745 with Lot numbers 613207-07V, 613221-07V, 613228-07V, 613249-07V, 613256-07V, 35206V, and 352699V.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2694-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2694-2014	Class II	Terminated	Voluntary: Firm initiated	2014-10-01	2014-09-24

Product code HMT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)