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.
Enforcement
- Recall Number
- Z-1153-2014
- Event ID
- 67440
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Carl Zeiss Meditec AG
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 19, 2014
- Initiation Date
- February 3, 2014
- Classification Date
- March 7, 2014
- Termination Date
- March 7, 2014
- Address
- Carl Zeiss Promenade 10, N/A, Jena, N/A, N/A, Germany
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.
Carl Zeiss Treatment pack, lot number M 130010, size M, may actually contain size S.
P/N 1462-333, Size M, Lot # M130010
US Distribution: NV only.
1 package containing 10 individual treatment packs