BEUDAMED
    FDA Recall Terminated

    AUTO REF/KERATOMETER ARK-1s

    Recall: Z-1348-2018 · Initiated December 20, 2017

    Recall

    Recall Number
    Z-1348-2018
    Event Number
    79553
    Firm
    Nidek Inc.
    FEI Number
    2936921
    Product Code
    HKO
    Status
    Terminated
    Root Cause
    Equipment maintenance
    Initiated
    December 20, 2017
    Terminated
    March 18, 2019
    Address
    47651 Westinghouse Dr, Fremont, CA, 94539-7474

    Description

    AUTO REF/KERATOMETER ARK-1s

    Reason

    There is possibly a difference between the measured dioptric value of the subjective measurement mode and the objective measurement mode on ARK-1s.

    Action

    Customers were notified via letter on about 12/20/2017. The letter instructed consignees that a representative from Marco Ophthalmic, Inc. will make arrangements for the affected unit to be picked up and replaced with an ARK-S unit that meets factory specifications.

    Distribution

    Distributed domestically to AK, AL, AR, CA, CO, DE, FL, GA, ID, IL, IN, MD, MI, MO, MT, NM, NY, OH, OK, PA, SC, TN, TX, VA, WA, WV.

    Quantity

    63 untis