FDA recall Z-0108-2019

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

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

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