CLASS II Device recall · Reported 1 Oct 2014 · FDA Enforcement Report

eye-pak 7407 Tray Support Cover recalled by Alcon Research

Alcon Research is recalling eye-pak 7407 Tray Support Cover, distributed nationwide in the US. The recall was initiated on 3 Jun 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesItem Number 8065740745 with Lot numbers 613207-07V, 613221-07V, 613228-07V, 613249-07V, 613256-07V, 35206V, and 352699V.

Quantity recalled2462

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2694-2014
FDA event ID: 68487
Recalling firm: Alcon Research, Fort Worth, TX
Classification: Class II
Status: Terminated
Recall initiated: 3 Jun 2014
FDA classified: 24 Sep 2014
Reported: 1 Oct 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Other Medical Devices

Timeline

3 Jun 2014	Recall initiated by company
24 Sep 2014	Classified by FDA	+113 days
1 Oct 2014	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The peel pouches of the Tray Support Covers may be insufficiently sealed so that sterility cannot be assured.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

eye-pak 7407 Tray Support Cover REF 8065740745

Where it was distributed

Worldwide Distribution - Nationwide Distribution and the countries of Australia, Belgium, and Canada.

Nationwide

Questions about this recall

Is eye-pak 7407 Tray Support Cover recalled?

Yes. Alcon Research recalled eye-pak 7407 Tray Support Cover on 3 Jun 2014. The recall is Class II and its status is Terminated. Recall number Z-2694-2014.

Why was it recalled?

The peel pouches of the Tray Support Covers may be insufficiently sealed so that sterility cannot be assured.

Which lots are affected?

Item Number 8065740745 with Lot numbers 613207-07V, 613221-07V, 613228-07V, 613249-07V, 613256-07V, 35206V, and 352699V.

Where was it sold?

Worldwide Distribution - Nationwide Distribution and the countries of Australia, Belgium, and Canada.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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