BEUDAMED
    FDA Enforcement Class III Terminated

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

    Recall: Z-0655-2019 · Reported December 26, 2018

    Enforcement

    Recall Number
    Z-0655-2019
    Event ID
    81529
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Nidek Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    December 26, 2018
    Initiation Date
    June 14, 2018
    Classification Date
    December 20, 2018
    Termination Date
    June 3, 2020
    Address
    47651 Westinghouse Dr, Fremont, CA, 94539-7474, United States

    Description

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

    Reason

    The lens bonding was incomplete on the refractor.

    Code Info

    Serial numbers 921042, 921043, 921044, 921045, 921046, 921047, 921048, 921049, 921050, 921051, 921052, 921053, 921054, 921055, 921056, 921057, 921058, 921059, 921060, 921061, 921062, 921063, 921064, 921065, 921066, 921067, 921068, 921069, 921070, 921071, 921072, 921073, 921074, 921075, 921076, 921077, 921078, 921079, 921080, 921081, 921084, 921085, 921086, 921087, 921088, 921089, 921090, 921091, 921092, 921093, 921094, 921095, 921096, 921097, 921098, 921099, 921100, 921101, 921102, 921103, 150028, 150029, 150030, 150031, 150032, 150033, 150034, 150035, 150036, 150037, 150038, 150039, 150040, 150041, 150042, 150043, 150044, 150045, 150046, 150047, 150048, 150049, 150050, 150051, and 150052

    Distribution

    Distribution was made to FL.

    Quantity

    85 instruments