BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2 LASER

    MDR report key: 1894984 · Received November 5, 2010

    Report

    Report Number
    3006695864-2010-00117
    Event Type
    Injury
    Date Received
    November 5, 2010
    Date of Event
    September 21, 2010
    Report Date
    October 6, 2010
    Manufacturer
    AMO MANUFACTURING USA LLC
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVAL: EQUIPMENT WAS EVALUATED BY A FIELD SERVICE ENGINEER (FSE) AFTER THE EVENT. MECHANICAL AND PERFORMANCE TEST WERE PERFORMED INCLUDING A VISUAL EXAMINATION. SYSTEM FOUND PERFORMING ACCORDING TO SPECIFICATIONS. FSE ALSO PERFORMED QUARTERLY PREVENTIVE MAINTENANCE THAT INCLUDED CLEANING THE OPTICS AND OPTIMIZING POWER BY ALIGNING ENERGY WHEEL AND DELIVERY SYSTEM.

    Description of Event or Problem · 1

    PATIENT HAD FLAP STRIAE S/P (STATUS POST) LASIK SURGERY ON (B)(6) 2010 AFFECTING BCVA OD. LIFT AND STRETCH OF FLAP ON (B)(6) 2010 TO IMPROVE BCVA (BEST CORRECTED VISUAL ACUITY). ON (B)(6)2010, PATIENT BCVA OD 20/30 -2. ON (B)(6) 2010, PATIENT BCVA OD 20/25 +2. ON (B)(6) 2010, PATIENT BCVA OD 20/20 -2.

    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 26 YR Other