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

Recall date

June 25, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0108-2019

FDA classification

Class II

Brand / firm

Carl Zeiss Meditec AG

Sold / distributed

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

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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