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Recall Observatory FDA recall evidence

Device product

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

Z-0108-2019

June 25, 2018

Class II

Product summary

Firm
Carl Zeiss Meditec AG
Event
Event 81000
Status
Terminated
Classification
Class II
Quantity
1
Official record key
device-enforcement:Z-0108-2019

Official wording

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.

Code information: Model: 700 Catalog Number: 000000-1932-169 Serial Number: 1185393 UDI: 04049471092080

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.