BEUDAMED
    FDA Enforcement Class II Terminated

    IOLMaster 700

    Recall: Z-1133-2021 · Reported February 24, 2021

    Enforcement

    Recall Number
    Z-1133-2021
    Event ID
    87055
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Carl Zeiss Meditec AG
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 24, 2021
    Initiation Date
    December 7, 2020
    Classification Date
    February 18, 2021
    Termination Date
    June 24, 2022
    Address
    Carl-Zeiss-Promenade 10, N/A, Jena, N/A, N/A, Germany

    Description

    IOLMaster 700

    Reason

    When using software 1.90.2.09 or 1.90.8.06 and using modality worklist functionality for patient data transfer, the selection of the patient in the patient list may not match the patient information displayed on the right side of the screen

    Code Info

    Model: IOLMaster 700 Catalog Number device: 000000-1932-169

    Distribution

    U.S.: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, Puerto Rico, SC, TX, UT, VA, VT, WA, WI, and WV. O.U.S.: Austria, Australia, Canada, Switzerland, Czech Republic, Germany, Denmark, Estonia, Spain, France, United Kingdom, Guatemala, Hong Kong, Indonesia, Ireland, India, Italy, Japan, Kuwait, Malaysia, Netherlands, New Zealand, Philippines, Poland, Portugal, Russia, Sweden, Singapore, Slovakia, Thailand, Taiwan, and South Africa.

    Quantity

    613 devices