BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-0108-2019 · Reported October 24, 2018

    Enforcement

    Recall Number
    Z-0108-2019
    Event ID
    81000
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Carl Zeiss Meditec AG
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 24, 2018
    Initiation Date
    June 25, 2018
    Classification Date
    October 15, 2018
    Termination Date
    January 15, 2021
    Address
    Carl-Zeiss-Promenade 10, N/A, Jena, N/A, N/A, Germany

    Description

    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.

    Code Info

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

    Distribution

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

    Quantity

    1