Z-1153-2014 Class II Terminated
FDA device recall Z-1153-2014 was initiated by Carl Zeiss Meditec AG on February 3, 2014 and is designated Class II. Reason for recall: Carl Zeiss Treatment pack, lot number M 130010, size M, may actually contain size S. The recall status is terminated (terminated March 7, 2014). Affected quantity: 1 package containing 10 individual treatment packs.
Recall Details
- Product Type
- Devices
- Report Date
- March 19, 2014
- Initiation Date
- February 3, 2014
- Termination Date
- March 7, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 package containing 10 individual treatment packs
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.
Reason for Recall
Carl Zeiss Treatment pack, lot number M 130010, size M, may actually contain size S.
Distribution Pattern
US Distribution: NV only.
Code Information
P/N 1462-333, Size M, Lot # M130010