BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KAMRA INLAY

    MDR report key: 6063225 · Received October 26, 2016

    Report

    Report Number
    MW5065657
    Event Type
    Injury
    Date Received
    October 26, 2016
    Date of Event
    August 31, 2016
    Report Date
    October 26, 2016
    Manufacturer
    ACUFOCUS
    Product Code
    LQE
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2016, PT HAD LASIK BOTH EYES WITH KAMRA INLAY PLACED LEFT EYE SAME DAY. ON (B)(6) 2016, PT PRESENTED WITH CORNEAL INFILTRATE (HSV), POSSIBLE INFLAMMATION / REJECTION OF INLAY PLACED ON ADD'L MEDS. ON (B)(6) 2016, SIGHT THREATENING INFECTION, CORNEAL REJECTING INLAY, HSV STILL PRESENT, INLAY REMOVED/CULTURED, STARTED PT ON FORTIFIED VANCOMYCIN/AMIKACIN/VIGAMOX / POLYTRIM, NO GROWTHS NOTED ON CULTURES. ON (B)(6) 2016, NEW SCRAPING GRAM STAIN, FEW NEGATIVE RODS, VERY FEW ECOLI. ON (B)(6) 2016, DEBULKED NECROTIC CORNEAL TISSUE LEFT EYE. ON (B)(6) 2016, AMBIODISK PLACED LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    709898 KAMRA INLAY LQE ACUFOCUS A-575-0715

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other