BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2 LASER

    MDR report key: 2163528 · Received November 5, 2010

    Report

    Report Number
    3006695864-2010-00123
    Event Type
    Injury
    Date Received
    November 5, 2010
    Date of Event
    September 23, 2010
    Report Date
    October 8, 2010
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), (EPITHELIAL IN-GROWTH). EVALUATION: EQUIPMENT WAS EVALUATED BY A FIELD SERVICE ENGINEER (FSE) AFTER THE EVENT. MECHANICAL AND PERFORMANCE TEST WERE PERFORMED INCLUDING A VISUAL EXAMINATION. FSE COMPLETED TROUBLESHOOTING OF OSCILLATOR BY PERFORMING ADJUSTMENTS AND SYSTEM MEETS AMO SPECIFICATION. NO PARTS WERE REPLACED.

    Description of Event or Problem · 1

    PRIMARY PROCEDURE ON (B)(6) 2005, NO COMPLICATIONS NOTED. PATIENT HAD LIFT FLAP ENH (ENHANCEMENT) OU ON (B)(6) 2010. ON (B)(6) 2010, PATIENT REFERRED BY CO-MANAGING OD FOR POSSIBLE FLAP LIFT FOR EPI IN-GROWTH OU. VASC 20/20 OD. DR DISCUSSED EPI IN-GROWTH WITH PATIENT AND DECIDED TO PROCEED WITH OD ONLY TODAY. FLAP LIFTED AND CLEANED. FLAP IN POSITION AND CLEAN 1 DAY POST OPERATION EPI IN-GROWTH REMOVAL ALL IN-GROWTH CLEARED AWAY. VASC 20/50 RE-CHECK ONE WEEK WITH CO-MANAGING DOCTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRALASE FS2 LASER HNO AMO MANUFACTURING USA, LLC 20003D

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other