BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2 LASER

    MDR report key: 2425107 · Received January 17, 2012

    Report

    Report Number
    3006695864-2012-00004
    Event Type
    Injury
    Date Received
    January 17, 2012
    Date of Event
    December 12, 2011
    Report Date
    December 20, 2011
    Manufacturer
    AMO MANUFACTURING USA LLC
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - (DIFFUSE LAMELLAR KERATITIS). EVALUATION: FIELD SERVICE SPECIALIST (FSS) VISITED SITE AFTER THE EVENT TO PERFORM A QUARTERLY PREVENTIVE MAINTENANCE. NO ADDITIONAL PROBLEMS OR OBSERVATIONS MADE. SYSTEM MEETS ALL AMO SPECIFICATIONS. METHOD: MECHANICAL TEST PERFORMED, VISUAL EXAMINATION. EVALUATION, CONCLUSION: DEVICE OPERATED WITHIN SPECIFICATION. NOTE: ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS (AMO) AT THE TIME OF THIS REPORT HAS BEEN SUBMITTED. SHOULD NEW INFORMATION THAT CHANGES THE FACTS AND/OR CONCLUSION OF THIS REPORT BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    PATIENT UNDERWENT UNEVENTFUL ILASIK (B)(6) 2011. PATIENT PRESENTED (B)(6) 2011 COMPLAINING OF CHANGE IN VISION. DLK NOTED. PATIENT BROUGHT BACK TO LASER SUITE, FLAP LIFTED AND INTERFACE IRRIGATED.

    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 40 YR Required Intervention