BEUDAMED
    FDA Enforcement Class II Terminated

    RT-5100 Refractor and RT-3100 Refractor; Distributed by MARCO Opthalmic: Manufactured by NIDEK CO., Ltd., Aichi, Japan. Instrument provides means of positioning spherical and cylindrical lenses, prisms and other optical devices in front of a subject's eyes for purpose of determining refractive error and binocular functions.

    Recall: Z-1853-2014 · Reported July 2, 2014

    Enforcement

    Recall Number
    Z-1853-2014
    Event ID
    68485
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Nidek Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 2, 2014
    Initiation Date
    June 9, 2014
    Classification Date
    June 23, 2014
    Termination Date
    October 30, 2015
    Address
    47651 Westinghouse Dr, N/A, Fremont, CA, 94539-7474, United States

    Description

    RT-5100 Refractor and RT-3100 Refractor; Distributed by MARCO Opthalmic: Manufactured by NIDEK CO., Ltd., Aichi, Japan. Instrument provides means of positioning spherical and cylindrical lenses, prisms and other optical devices in front of a subject's eyes for purpose of determining refractive error and binocular functions.

    Reason

    Near Point Chart Arm of RT 5100 and RT-3100 Refractors may lower spontaneously with potential for patient injury.

    Code Info

    RT-5100 and RT-3100, various serial numbers.

    Distribution

    US distribution only.

    Quantity

    ~4,285 units RT-5100; 167 units of RT-3100