Recall Z-1133-2021— Carl Zeiss Meditec AG
Class II · Terminated
Class II FDA medical device recall by Carl Zeiss Meditec AG, initiated 2020-12-07, terminated 2022-06-24. It names one FDA 510(k) clearance: K173771. Product: IOLMaster 700. Reason: When using software 1.90.2.09 or 1.90.8.06 and using modality worklist functionality for patient data transfer, the selection of the patient in the patient list may not match the patient information displayed on the right side of the screen.
- Recalling firm
- Carl Zeiss Meditec AG
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-12-07
- Terminated
- 2022-06-24
- Firm location
- Jena, N/A, Germany
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
IOLMaster 700
Reason for recall
When using software 1.90.2.09 or 1.90.8.06 and using modality worklist functionality for patient data transfer, the selection of the patient in the patient list may not match the patient information displayed on the right side of the screen
Data sourced from openFDA. This site is unofficial and independent of the FDA.