Recall Z-0358-2016 ยท HJO Biomicroscope, Slit-Lamp, Ac-Powered
Carl Zeiss Meditec AG
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.
| Date | Dec 1, 2015 (initiated Oct 27, 2015) |
| Status | Terminated |
| Reason | IOL Master software versions 7.5 and 7.7 calculation printouts and exported reports can contain the wrong IOL power data. |
| Root cause | Software design |
| Action | 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. |
| Quantity | 1882 |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |