Data Foundry

Medical device recalls 2021

IOLMaster 700 — Class II medical device recall Z-1133-2021

Terminated recall by Carl Zeiss Meditec AG, reported 2021-02-24, distributed in AL, AR, AZ, CA, CO, CT, DE, FL…. When using software 1.90.2.09 or 1.90.8.06 and using modality worklist functionality for patient data transfer

Recall numberZ-1133-2021
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmCarl Zeiss Meditec AG, Jena, N/A, Germany
Recall initiated2020-12-07
Classified2021-02-18
Reported by FDA2021-02-24
Terminated2022-06-24
DistributedAL, 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
Countries outside the USAT, AU, CA, CH, CZ, DE, DK, EE, ES, FR, GB, GT, HK, ID, IE, IN, IT, JP, KW, MY, NL, NZ, PH, PL, PT, RU, SE, SG, SK, TH, TW, ZA
Quantity613 devices
Reason classessoftware

Product

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

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1133-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.