BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE IFS LASER

    MDR report key: 1780991 · Received July 28, 2010

    Report

    Report Number
    3006695864-2010-00087
    Event Type
    Injury
    Date Received
    July 28, 2010
    Date of Event
    June 10, 2010
    Report Date
    July 26, 2010
    Manufacturer
    AMO MANUFACTURING USA, LLC.
    Product Code
    HNO
    PMA / PMN Number
    K073404
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: ON JUNE 21, 2010, A FIELD SERVICE ENGINEER WAS DISPATCHED TO INVESTIGATE THE LASER AND DURING HIS VISIT THERE WAS NO INDICATION THAT THE EQUIPMENT HAD A MALFUNCTION. THE REPORTING SURGEON EXCLUDED THE LASER BEING CONTRIBUTORY TO THE EVENT AND SAID IT WAS A USER ISSUE.

    Description of Event or Problem · 1

    THE INTRALASE IFS LASER WAS USED TO CREATE A CORNEAL FLAP FOR LASIK SURGERY ON (B)(6) 2010. IT WAS REPORTED THAT SIDE CUT OF RIGHT EYE COULD NOT BE OPENED. THEN SURGEON RECREATED A FLAP IN THE SAME DEPTH. DURING OPENING A SMALL CORNEA PIECE WAS REMOVED. THE REPORTING SURGEON CHECKED WITH SLIT LAMP AND DECIDED NOT TO LIFT FLAP. POST OP BCVA 0.6. F/U ON THE EVENT REVEALED THAT AS OF (B)(6) 2010 PT BCVA WAS 0.8.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRALASE IFS LASER HNO AMO MANUFACTURING USA, LLC. 20007

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Other