BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE IFS LASER

    MDR report key: 1891271 · Received October 27, 2010

    Report

    Report Number
    3006695864-2010-00099
    Event Type
    Injury
    Date Received
    October 27, 2010
    Report Date
    June 20, 2010
    Manufacturer
    AMO MANUFACTURING USA LLC
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: AMO FIELD SERVICE ENGINEERS AND CLINICAL DEVELOPMENT SPECIALISTS HAVE BEEN ON SITE FOR CHECKING, INVESTIGATING AND EVALUATING OF THE INTRALASE LASER IN RELATIONSHIP TO THE REPORTED EVENTS AS WELL AS FOR RETRAINING AND ADVISING HOSPITAL STAFF IN ADJUSTING AND USING OF THE LASER. DURING THE LASER SYSTEM CHECKS CONDUCTED ON SITE, IT WAS CONCLUDED THAT THE LASER SEEMED TO HAVE A LASER ENERGY ISSUE (AMPLIFIER AND OSCILLATOR). THESE FINDINGS MIGHT BE CONSIDERED AS POTENTIAL ROOT CAUSES FOR THE REPORTED DIFFICULT FLAP LIFTS. THE AMO FIELD SERVICE ENGINEERS AND CLINICAL DEVELOPMENT SPECIALISTS ADJUSTED THE LASER SETTINGS. THERE WAS NO NEED TO REPLACE COMPONENTS. AFTER FINE TUNING OF AMPLIFIER AND OSCILLATOR AND RETRAINING OF HOSPITAL STAFF, THE ISSUES SEEMED TO BE SOLVED.

    Description of Event or Problem · 1

    INTRALASE FS LASER WAS USED FOR CREATION OF CHANNELS FOR INTACS PROCEDURE. SURGEON REPORTED 1 PERFORATION IN ANTERIOR CHAMBER WITH INTACS. ALSO WHEN CUTTING CHANNELS FOR THE IMPLANTATION OF INTACS, THE SURGEON REPORTED DIFFICULTIES TO GET INTACS THROUGH THESE 'STICKY' CHANNELS (SIMILAR TO DIFFICULT FLAP LIFTS). PT BCVA. PRE-OP VA = 6/10. POST-OP VA = 4/10.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other