BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KAMRA

    MDR report key: 5345432 · Received January 5, 2016

    Report

    Report Number
    3008401069-2016-00001
    Event Type
    Injury
    Date Received
    January 5, 2016
    Date of Event
    December 2, 2015
    Report Date
    May 3, 2016
    Manufacturer
    ACUFOCUS, INC.
    Product Code
    LQE
    UDI-DI
    00813359020007
    PMA / PMN Number
    P120023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    ON (B)(6) 2015, ACUFOCUS, INC. BECAME AWARE OF A CANAL WASHOUT BEING PERFORMED ON A (B)(6)YEAR OLD MALE PATIENT, ONE (1) WEEK POSTOPERATIVELY DUE TO EPITHELIAL CELLS IN THE CANAL OF THE POCKET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5370 KAMRA CORNEAL INLAY LQE ACUFOCUS, INC. ACI 7000 A546-0315 00813359020007

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention