Recall Z-0108-2019 ยท HJO Biomicroscope, Slit-Lamp, Ac-Powered
Carl Zeiss Meditec AG
Carl Zeiss Meditec AG, Goeschwitzer Strasse 51-52 07745 Jena, Germany, IOLMaster 700, REF 1932-169 SN 1185393 2017-09-01
| Date | Jun 25, 2018 |
| Status | Terminated |
| Reason | Calibration setting was incorrectly entered during manufacturing causing the optical coherence tomography (OCT) to obtain the incorrect two-dimensional images of ocular structures of the anterior and posterior segments of the eye. |
| Root cause | Employee error |
| Action | On 08/06/2018 the firm sent a Field Safety Corrective Action letter to customers via FedEx Priority Overnight service informing them that based on routine post market surveillance activities, we have information that this specific IOLMaster 700 device is incorrectly calibrated. The calibration value for axial length measurement was not entered correctly in the device settings during the manufacturing process. The transmission discrepancy leads to an error during the axial length measurement of approx. 0.25mm. A deviation in the axial length of this magnitude results in an error of Single unit. |
| Quantity | 1 |
| Distribution | US: CA (Mountain View and San Jose) A single system. No distributed OUS. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170171 | IOLMaster 700 Carl Zeiss Meditec, AG, Apr 6, 2017 |