IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocu
FDA device recall Z-0358-2016 · posted 2015-12-01 · Terminated
Recall details
- Recalling firm
- Carl Zeiss Meditec AG
- Reason for recall
- IOL Master software versions 7.5 and 7.7 calculation printouts and exported reports can contain the wrong IOL power data.
- Action taken
- Urgent Medical Device Correction letters will be mailed on Friday, November 13, 2015 as the IOL SW update material is now available. Letter informs customers of the issue and provide instructions for identifying the software version and for installing the software update with illustrations. All customers are requested to complete and return the confirmation form to Stericycle as soon as the upgrade is complete or it has been determined that your unit is not running the affected version of the software.
- Root cause
- Software design
- Status
- Terminated
- Product code
- HJO
- Quantity affected
- 1882
- Distribution
- Nationwide Distribution.
- Date initiated
- 2015-10-27
- Date posted
- 2015-12-01
- Date terminated
- 2016-06-06
- Location
- Jena, Germany
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IOLMASTER 500 (K122418) | Carl Zeiss Meditec, AG | 2013-04-12 |
| IOLMASTER 500 (K101182) | Carl Zeiss Meditec, AG | 2010-11-03 |
| IOLMASTER (K993357) | Carl Zeiss, Inc. | 2000-03-20 |