BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KAMRA

    MDR report key: 5248858 · Received November 25, 2015

    Report

    Report Number
    3008401069-2015-00013
    Event Type
    Injury
    Date Received
    November 25, 2015
    Date of Event
    November 19, 2013
    Report Date
    November 24, 2015
    Manufacturer
    ACUFOCUS, INC.
    Product Code
    LQE
    PMA / PMN Number
    P120023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 THAT A (B)(6) YEAR OLD, MALE PATIENT WAS REFERRED TO THE (B)(6) HOSPITAL DUE TO A SUSPECTED INFECTION IN THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779478 KAMRA CORNEAL INLAY LQE ACUFOCUS, INC. ACI 7000 A424-0912

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R