Z-1153-2014Class II

Treatment packs used on the VisuMax Laser Keratome. Size M Manufactured by Carl Zeiss Meditec AG, Jena...

Name: Z-1153-2014 Treatment packs used on the VisuMax Laser Keratome. Size M Manufactured by Carl Zeiss Meditec AG, Jena...
Creator: Carl Zeiss Meditec AG
Published: 2014-02-03
License: https://open.fda.gov/license/

Carl Zeiss Meditec Inc / initiated 2014-02-03 / Terminated

FDA source

Carl Zeiss Meditec AG began a recall of 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... on 2014-02-03. FDA classified it as Class II and gives the reason as "Carl Zeiss Treatment pack, lot number M 130010, size M, may actually contain size S". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1153-2014
Classification: Class II
Status: Terminated
Initiated: 2014-02-03
Posted: 2014-03-07
Terminated: 2014-03-07
Recalling firm: Carl Zeiss Meditec Inc
Product: 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.
Product code: HQF Laser, Ophthalmic
Reason for recall: Carl Zeiss Treatment pack, lot number M 130010, size M, may actually contain size S.
FDA root cause: Mixed-up of materials/components
Action: The firm, Zeiss, sent an "Important Field Safety Advisory Note" letter dated February 3, 2014 to its customer. Letter indicates that a phone call preceded the letter on January 23, 2014. The letter also describes the product, problem and actions to be taken. The customers were instructed to quarantine all treatment packs size "M", batch number M 130010; return the material to Carl Zeiss Meditec, Inc., 5160 Hacienda Dr, Dublin, CA 94568 and Zeiss will issue a credit for all material received, upon receipt of the returned materia, and to complete and return the Conformation Form with the envelop provided. If you have any questions regarding this field corrective action, please call 925-557-4832 or email at [email protected].
Quantity in commerce: 1 package containing 10 individual treatment packs
Distribution: US Distribution: NV only.
Product codes and lots: P/N 1462-333, Size M, Lot # M130010

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1153-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1153-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-19	2014-03-07

Product code HQF

K100253Class IIVisumax Laser KeratomeCarl Zeiss Meditec, AG / cleared 2010-07-08

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

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)