Carl Zeiss Meditec AG, Goeschwitzer Strasse 51-52 07745 Jena, Germany, IOLMaster 700, REF 1932-169 SN 1185393 2017-09-01
Reported: October 24, 2018 Initiated: June 25, 2018 #Z-0108-2019
Product Description
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.
Details
- Recalling Firm
- Carl Zeiss Meditec AG
- Units Affected
- 1
- Distribution
- US: CA (Mountain View and San Jose) A single system. No distributed OUS.
- Location
- Jena, N/A
Frequently Asked Questions
What product was recalled? ▼
Carl Zeiss Meditec AG, Goeschwitzer Strasse 51-52 07745 Jena, Germany, IOLMaster 700, REF 1932-169 SN 1185393 2017-09-01. Recalled by Carl Zeiss Meditec AG. Units affected: 1.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 24, 2018. Severity: Moderate. Recall number: Z-0108-2019.
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