Recall Z-1153-2014 ยท HQF Laser, Ophthalmic
Carl Zeiss Meditec AG
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 c
| Date | Mar 7, 2014 (initiated Feb 3, 2014) |
| Status | Terminated |
| Reason | Carl Zeiss Treatment pack, lot number M 130010, size M, may actually contain size S. |
| 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 envelo |
| Quantity | 1 package containing 10 individual treatment packs |
| Distribution | US Distribution: NV only. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100253 | VISUMAX LASER KERATOME Carl Zeiss Meditec, AG, Jul 8, 2010 |