FDA Device recall Z-1153-2014
Treatment packs used on the VisuMax Laser Keratome
- FDA Device
- Class II
- terminated
- Published 2014-03-19
On 2014-03-19 the FDA classified a Class II recall of Treatment packs used on the VisuMax Laser Keratome by Carl Zeiss Meditec Ag, citing carl Zeiss Treatment pack, lot number M 130010, size M, may actually contain size S.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1153-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-02-03 |
| Published | 2014-03-19 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Carl Zeiss Meditec Ag |
| Distribution | NV |
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.
Reason
Carl Zeiss Treatment pack, lot number M 130010, size M, may actually contain size S.
Identifiers
| code_info | P/N 1462-333, Size M, Lot # M130010 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1153-2014%22
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