BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KAMRA

    MDR report key: 5152949 · Received October 15, 2015

    Report

    Report Number
    3008401069-2015-00003
    Event Type
    Injury
    Date Received
    October 15, 2015
    Date of Event
    September 14, 2015
    Report Date
    October 15, 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

    ACTUAL DEVICE REMAINS IMPLANTED IN THE PATIENT'S EYE AND WAS NOT EVALUATED. THE INSTRUCTIONS FOR USE FOR THE KAMRA INLAY, INVOLVING BOTH THE UNITED STATES (US) AND OUTSIDE THE UNITED STATES (OUS) PRODUCT LABELING (IFU P/N'S 61017 AND 61016-05, RESPECTIVELY), CONTAIN STATEMENTS WARNING AGAINST THE CREATION OF A FEMTOSECOND LASER FLAP WITH THE KAMRA INLAY IN PLACE. THE DOCTOR INVOLVED IN THIS EVENT WAS INFORMED OF THIS WARNING AND SIGNED AN ACKNOWLEDGEMENT ON (B)(6) 2014 WHICH IS ON FILE AT ACUFOCUS, INC. DEVICE REMAINS IMPLANTED IN THE PATIENT

    Description of Event or Problem · 1

    ON (B)(6) 2015, THE DOCTOR REPORTED HE CUT A FEMTOSECOND (F/S) FLAP ON A PATIENT THAT HAD A KAMRA INLAY IMPLANTED. THE DOCTOR REPORTED THE INLAY TURNED GREYISH, CORNEA IS NOT CLEAR, INLAY IS DEPRESSED IN THE STROMA, AND CORNEAL EDEMA IS PRESENT. AN AGGRESSIVE STEROID REGIMEN OF TOBRASON AND HYLOKOMOD WAS INITIATED ON (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684199 KAMRA CORNEAL INLAY LQE ACUFOCUS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention