BEUDAMED
    FDA Recall 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 · Initiated June 9, 2014

    Recall

    Recall Number
    Z-1853-2014
    Event Number
    68485
    Firm
    Nidek Inc
    FEI Number
    2936921
    Product Code
    HKN
    Status
    Terminated
    Root Cause
    Use error
    Initiated
    June 9, 2014
    Posted
    June 23, 2014
    Terminated
    October 30, 2015
    Address
    47651 Westinghouse Dr, Fremont, CA, 94539-7474

    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.

    Action

    Recall/Field Correction letters were sent to doctors on June 9, 2014 with a preventive maintenance instruction to be performed on the device by user. Also included are the necessary tools to perform actions. Customers are to complete and return the Recall Response Card. Questions are to be directed to Customer Service. Contact Information: Customer Service: 1-800-891-1772 E-mail: RT-5100 [email protected]

    Distribution

    US distribution only.

    Quantity

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