Treatment packs used on the VisuMax Laser Keratome — Class II medical device recall Z-1153-2014
Terminated recall by Carl Zeiss Meditec AG, reported 2014-03-19, distributed in NV. Carl Zeiss Treatment pack, lot number M 130010, size M, may actually contain size S.
| Recall number | Z-1153-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Carl Zeiss Meditec AG, Jena, N/A, Germany |
| Recall initiated | 2014-02-03 |
| Classified | 2014-03-07 |
| Reported by FDA | 2014-03-19 |
| Terminated | 2014-03-07 |
| Distributed | NV |
| Lot numbers | M130010 |
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 for recall
Carl Zeiss Treatment pack, lot number M 130010, size M, may actually contain size S.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1153-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.