Device 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.
Z-1153-2014
Product summary
- Event
- Event 67440
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1 package containing 10 individual treatment packs
- Official record key
device-enforcement:Z-1153-2014
Official wording
Reason: Carl Zeiss Treatment pack, lot number M 130010, size M, may actually contain size S.
Code information: P/N 1462-333, Size M, Lot # M130010
Distribution pattern: US Distribution: NV only.
Derived failure modes
-
Unknown
Carl Zeiss Treatment pack, lot number M 130010, size M, may actually contain size S.