# FDA recall Z-0108-2019

> **Carl Zeiss Meditec AG** · Class II · device recall initiated 2018-06-25.

## Product

Carl Zeiss Meditec AG, Goeschwitzer Strasse 51-52 07745 Jena, Germany,  IOLMaster 700, REF 1932-169  SN 1185393  2017-09-01

## Reason for recall

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.

## Distribution

US: CA (Mountain View and San Jose)    A single system.  No distributed OUS.

## Key facts

- **Recall number:** Z-0108-2019
- **Recalling firm:** Carl Zeiss Meditec AG
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-06-25
- **Report date:** 2018-10-24
- **Termination date:** 2021-01-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Jena, N/A, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0108-2019

## Citation

> AI Analytics. FDA recall Z-0108-2019. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-0108-2019. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*