BEUDAMED
    FDA Enforcement Class II 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 · Reported March 30, 2016

    Enforcement

    Recall Number
    Z-1245-2016
    Event ID
    73316
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Nidek Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 30, 2016
    Initiation Date
    February 29, 2016
    Classification Date
    March 24, 2016
    Termination Date
    September 24, 2018
    Address
    47651 Westinghouse Dr, N/A, Fremont, CA, 94539-7474, United States

    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.

    Code Info

    serial numbers: See attached distribution list. 128 RT -3100 and 2565 RT-5100.

    Distribution

    US Nationwide Distribution

    Quantity

    2703 separate serial numbers