CLASS II Device recall · Reported 19 Mar 2014 · FDA Enforcement Report

Treatment packs used on the VisuMax Laser Keratome recalled

Carl Zeiss Meditec is recalling Treatment packs used on the VisuMax Laser Keratome, distributed in Nevada. The recall was initiated on 3 Feb 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesP/N 1462-333, Size M, Lot # M130010

Quantity recalled1 package containing 10 individual treatment packs

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-1153-2014
FDA event ID: 67440
Recalling firm: Carl Zeiss Meditec, Jena, N/A
Classification: Class II
Status: Terminated
Recall initiated: 3 Feb 2014
FDA classified: 7 Mar 2014
Reported: 19 Mar 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

3 Feb 2014	Recall initiated by company
7 Mar 2014	Classified by FDA	+32 days
19 Mar 2014	Published in enforcement report	+12 days

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

Reason for recall

Carl Zeiss Treatment pack, lot number M 130010, size M, may actually contain size S.

Product as listed by the FDA

Treatment packs used on the VisuMax Laser Keratome. Size M Manufactured by Carl Zeiss Meditec AG, Jena, Germany. The VisuMax Laser Keratome is indicated for the following: In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring lamellar resection of the cornea. Patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea. In the creation of a lamellar cut/resection of the cornea for lamellar keratoplasty. In the creation of a cut/incision for penetrating keratoplasty and corneal harvesting.

Where it was distributed

US Distribution: NV only.

Nevada

Questions about this recall

Why was it recalled?

Carl Zeiss Treatment pack, lot number M 130010, size M, may actually contain size S.

Which lots are affected?

P/N 1462-333, Size M, Lot # M130010

Where was it sold?

US Distribution: NV only.

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 26 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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