BEUDAMED
    FDA Recall Terminated

    RT-5100 (Epic 5100) Refractor and RT 3100 Refractor: Product Usage: Instrument providing means of positioning spherical and cylindrical lenses, prisms and other optical devices in front of a subjects eye for purpose of determining refractive error and binocular functions.

    Recall: Z-1245-2016 · Initiated February 29, 2016

    Recall

    Recall Number
    Z-1245-2016
    Event Number
    73316
    Firm
    Nidek Inc
    FEI Number
    2936921
    Product Code
    HKN
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    February 29, 2016
    Posted
    March 24, 2016
    Terminated
    September 24, 2018
    Address
    47651 Westinghouse Dr, Fremont, CA, 94539-7474

    Description

    RT-5100 (Epic 5100) Refractor and RT 3100 Refractor: Product Usage: Instrument providing means of positioning spherical and cylindrical lenses, prisms and other optical devices in front of a subjects eye for purpose of determining refractive error and binocular functions.

    Reason

    There has been a reoccurrence of an issue on the RT 5100 and RT 3100 Refractor of the Near Point Chart Arm lowering spontaneously with potential for slight injury to face or nose of patient.

    Action

    Nidek sent a Recall letters dated February 29, 2016 to all affected site. The letter identified the affected product, problem and actions to be taken. Nidek Customer Service will be replacing the affected product with new parts to address this recall. For questions call Customer Service at 1-800-722-0219.

    Distribution

    US Nationwide Distribution

    Quantity

    2703 separate serial numbers