Treatment packs used on the VisuMax Laser Keratome. Size M Manufactured by Carl Zeiss Meditec AG, Jena, Germany. The Vis
FDA device recall Z-1153-2014 · posted 2014-03-07 · Terminated
Recall details
- Recalling firm
- Carl Zeiss Meditec AG
- Reason for recall
- Carl Zeiss Treatment pack, lot number M 130010, size M, may actually contain size S.
- Action taken
- 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 envelop provided. If you have any questions regarding this field corrective action, please call 925-557-4832 or email at paul.shahan@zeiss.com.
- Root cause
- Mixed-up of materials/components
- Status
- Terminated
- Product code
- HQF
- Quantity affected
- 1 package containing 10 individual treatment packs
- Distribution
- US Distribution: NV only.
- Date initiated
- 2014-02-03
- Date posted
- 2014-03-07
- Date terminated
- 2014-03-07
- Location
- Jena, Germany
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VISUMAX LASER KERATOME (K100253) | Carl Zeiss Meditec, AG | 2010-07-08 |