BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE IFS LASER

    MDR report key: 2062599 · Received April 8, 2011

    Report

    Report Number
    3006695864-2011-00025
    Event Type
    Injury
    Date Received
    April 8, 2011
    Date of Event
    February 25, 2011
    Report Date
    April 8, 2011
    Manufacturer
    AMO MANUFACTURING USA, LLC.
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL: FIELD SERVICE SPECIALIST (FSS) SERVICED LASER AND PERFORMED Q1 2011 PREVENTIVE MAINTENANCE, CLEANED OPTICS AND OPTIMIZED POWER. NO MAJOR ADJUSTMENTS REQUIRED. SYSTEM MEETS AMO SPECS. ALSO ADJUSTED ENCODER FOR PROPER TRANSITION. PERFORMED Z OFFSET CALIBRATION AND UPDATED TO DOCTOR'S CONE. PERFORMED Z SCALE CALIBRATION, ALL VALUES WITHIN SPEC, NO ADJUSTMENT REQUIRED. CUT AND MEASURED GEL, ALL WITHIN SPECS. REBOOTED LASER. CLINICAL DEVELOPMENT MANAGER (CDM) VISITED SITE AFTER EVENT AND FSS VISIT. SHE PERFORMED GEL TESTING AND VERIFIED CURRENT SURGICAL SETTINGS. NO CHANGES WERE DONE. NINE FLAPS WERE CREATED WITHOUT ISSUE.

    Description of Event or Problem · 1

    ACCOUNT REPORTED THIN FLAPS WHEN CUTTING 90, 120 MICRONS. VERTICAL GAS BREAKTHROUGH ON BOTH EYES WHILE ATTEMPTING 90U FLAPS. PRK DONE SAME DAY AND BANDAGE LENSES PLACED. PREOP BCVA: R-20/15, L-20/15. BCVA ON (B)(6) 2011: R-20/30, L-20-25.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRALASE IFS LASER HNO AMO MANUFACTURING USA, LLC. J20007D

    Patients

    Seq Age Sex Outcome Treatment
    1 Other