BEUDAMED
    FDA Recall Terminated

    RT-5100 Refractor, a component of the Epic-5100 System.

    Recall: Z-0655-2019 · Initiated June 14, 2018

    Recall

    Recall Number
    Z-0655-2019
    Event Number
    81529
    Firm
    Nidek Inc.
    FEI Number
    2936921
    Product Code
    HKN
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    June 14, 2018
    Terminated
    June 3, 2020
    Address
    47651 Westinghouse Dr, Fremont, CA, 94539-7474

    Description

    RT-5100 Refractor, a component of the Epic-5100 System.

    Reason

    The lens bonding was incomplete on the refractor.

    Action

    The recalling firm called the sole distributor on 6/14/2018 to determine the quantity of instruments still in their control. During the phone call, the distributor was also notified of the invoice numbers that show the serial numbers involved, was asked to segregate the affected product, and a schedule was discussed for the recalling firm's technicians to visit the distributor for correction of the product.

    Distribution

    Distribution was made to FL.

    Quantity

    85 instruments