BEUDAMED
    FDA Enforcement Class II Terminated

    AUTO REF/KERATOMETER ARK-1s

    Recall: Z-1348-2018 · Reported April 18, 2018

    Enforcement

    Recall Number
    Z-1348-2018
    Event ID
    79553
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Nidek Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 18, 2018
    Initiation Date
    December 20, 2017
    Classification Date
    April 10, 2018
    Termination Date
    March 18, 2019
    Address
    47651 Westinghouse Dr, Fremont, CA, 94539-7474, United States

    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.

    Code Info

    Model No. ARK-1s, Serial No. 620337, 620340, 620341, 620343, 620345, 620349, 620350, 620355, 620356, 620359, 620363, 620370, 620371, 620374, 620376, 620377, 620380, 620381, 620384, 620387, 620389, 620391, 620394, 620398, 620400, 620403, 620404, 620407, 620410, 620412, 620415, 620417, 620418, 620420, 620422, 620425, 620427, 620429, 620433, 620435, 620437, 620440, 620444, 620445, 620447, 620450, 620452, 620454, 620455, 620459, 620462, 620464, 620466, 620469, 620471, 620474, 620477, 620478, 620480, 620482, 620485, 620487, 620489.

    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