BEUDAMED
    FDA Adverse Event Other Summary report: N

    INTERLASE

    MDR report key: 2308689 · Received October 21, 2011

    Report

    Report Number
    MW5022772
    Event Type
    Other
    Date Received
    October 21, 2011
    Date of Event
    October 14, 2011
    Report Date
    October 21, 2011
    Product Code
    LQJ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    UNSUCCESSFUL INTERLASE (CUSTOM LASIK) PERFORMED. DURING THE LEFT EYE SURGERY, THE FLAP WAS CUT TOO THIN TO PROCESS. THE OPERATION WAS ABORTED, PT WAS EXAMINED THE DAY FOLLOWING PROCEDURE, PT WAS FINALLY INFORMED OF REAL COMPLICATION 4 DAYS LATER. EXCIMER LASER PRODUCTS WERE USED, UNSURE OF MAKES AND MODELS. SURGERY DATE WAS (B)(6) 2011. I AM THE PATIENT JUST TRYING TO PROVIDE DUE DILIGENCE, THIS IS REPORTED CORRECTLY. THE SURGERY WAS PERFORMED AT (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERLASE NONE LQJ

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other