Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0108-2019 — Carl Zeiss Meditec AG, Goeschwitzer Strasse 51-52 07745 Jena, Germany, IOLMaster 700, REF 1932-169 SN 1185393 2017-09-01

U.S. FDA — Device Enforcement · Germany · 2018-06-25 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0108-2019
Date of alert
2018-06-25
Country / jurisdiction
Germany
Risk level
Class II
Risk type
recall
Brand
Carl Zeiss Meditec AG
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
04049471092080
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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