BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS3 LASER

    MDR report key: 2425096 · Received January 17, 2012

    Report

    Report Number
    3006695864-2012-00003
    Event Type
    Injury
    Date Received
    January 17, 2012
    Date of Event
    December 11, 2011
    Report Date
    December 19, 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). (B)(4) (DIFFUSE LAMELLAR KERATITIS - STAGE III). EVALUATION: FIELD SERVICE SPECIALIST (FSS) VISITED SITE PRIOR TO THE EVENT TO PERFORM A PREVENTIVE MAINTENANCE. NO PROBLEMS WITH THE EQUIPMENT WERE FOUND. METHOD: MECHANICAL TEST PERFORMED. VISUAL EXAMINATION. EVALUATION, CONCLUSION: DEVICE OPERATED WITHIN SPECIFICATIONS. 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 ON (B)(6) 2011. PATIENT PRESENTED AT 1 DAY POST-OP WITH TRACE DLK OS. INCREASED DUREZOL AND RE-CHECKED (B)(6) 2011. PATIENT HAD INCREASE IN DLK TO GRADE 1, CONTINUED MEDICATION ADDED STEROID UNG HS. RE-CHECKED DAY 3 AND NOTED DLK GRADE 2-3. BROUGHT PATIENT TO LASER SUITE AND LIFTED FLAP AND IRRIGATED. LAST CHECK (B)(6) 2011 - VASC 20/20 OD, 20/20 OS. DLK RESOLVING. PATIENT TO TAPER STEROIDS AND RE-CHECK IN 3 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRALASE FS3 LASER HNO AMO MANUFACTURING USA LLC 20004

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention