Carl Zeiss Meditec AG: Medical Device Recall in 2014 - (Recall #: Z-1153-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: February 3, 2014

Date Posted: March 19, 2014

Recall Number: Z-1153-2014

Event ID: 67440

Reason for Recall:

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

Status: Terminated

Product Quantity: 1 package containing 10 individual treatment packs

Code Information:

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

Distribution Pattern:

US Distribution: NV only.

Voluntary or Mandated:

Voluntary: Firm initiated