FDA Device recall Z-1133-2021
IOLMaster 700
- FDA Device
- Class II
- terminated
- Published 2021-02-24
On 2021-02-24 the FDA classified a Class II recall of IOLMaster 700 by Carl Zeiss Meditec Ag, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1133-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-12-07 |
| Published | 2021-02-24 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Carl Zeiss Meditec Ag |
| Distribution | AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, PR, SC, TX, UT, VA, VT, WA, WI, WV |
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
Identifiers
| code_info | Model: IOLMaster 700 Catalog Number device: 000000-1932-169 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1133-2021%22
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