IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil.
Recall
- Recall Number
- Z-0358-2016
- Event Number
- 72564
- Firm
- Carl Zeiss Meditec AG Carl Zeiss Promenade 10 Jena Germany
- FEI Number
- 3001362763
- Product Code
- HJO
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- October 27, 2015
- Posted
- December 1, 2015
- Terminated
- June 6, 2016
Description
IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil.
IOL Master software versions 7.5 and 7.7 calculation printouts and exported reports can contain the wrong IOL power data.
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.
Nationwide Distribution.
1882