Recall Z-0108-2019— Carl Zeiss Meditec AG
Class II · Terminated
Class II FDA medical device recall by Carl Zeiss Meditec AG, initiated 2018-06-25, terminated 2021-01-15. It names one FDA 510(k) clearance: K170171. Product: Carl Zeiss Meditec AG, Goeschwitzer Strasse 51-52 07745 Jena, Germany, IOLMaster 700, REF 1932-169 SN 1185393 2017-09-01. Reason: 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..
- Recalling firm
- Carl Zeiss Meditec AG
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-06-25
- Terminated
- 2021-01-15
- 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
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.