BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 3130365 · Received May 24, 2013

    Report

    Report Number
    3006695864-2013-00177
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    April 26, 2013
    Report Date
    April 26, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2013, AMO'S FIELD SERVICE ENGINEER WAS ONSITE TO PERFORM PREVENTATIVE MAINTENANCE (PM). PM WAS COMPLETED AND SYSTEM MEETS AMO SPECIFICATIONS. CUSTOMER IS NOT SURE EXACTLY WHAT THE CAUSE OF THE DLK IS BUT STATED THEY ARE SURE IT IS NOT FROM OUR LASER. PLACEHOLDER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED 2 CASES OF DIFFUSE LAMELLAR KERATITIS (DLK). PATIENT HAD STAGE 1 DLK ON BOTH EYES. PATIENT WAS TREATED WITH DUREZOL. NO LOSS OF BEST CORRECTED VISUAL ACUITY (BCVA) WAS REPORTED. ADDITIONAL FOLLOW-UP WAS OBTAINED. DLK WAS RESOLVED ON (B)(6) 2013. BCVA WAS 20/20 ON BOTH EYES AND NO LOSS OF BCVA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232182 INTRALASE FS2 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20003D

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Other