BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 2944831 · Received February 5, 2013

    Report

    Report Number
    3006695864-2013-00027
    Event Type
    Injury
    Date Received
    February 5, 2013
    Date of Event
    January 6, 2013
    Report Date
    January 7, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: CLINICAL DEVELOPMENT MANAGER (CDM) DISCUSSED WITH THE CUSTOMER REGARDING USING PRED FORTE 1%, CHECKING CLEANING REGIMEN AND WHEN STEAM STERILIZER WAS LAST SERVICED. CUSTOMER REPLACED SEALS ON STERILIZER ON (B)(6) 2013. SPORE TESTING PERFORMED ROUTINELY ON STERILIZER. THE FSE WAS ON SITE (B)(6) 2013 FOR PREVENTATIVE MAINTENANCE (PM). FSE GELLED LASER AT 0.85 AND CURRENT SURGICAL SETTING IS AT 1.00. SYSTEM WAS TESTED AND MEETS AMO SPECIFICATIONS. CUSTOMER DID NOT HAVE ANY DLK CASES REPORTED ON NEXT SURGERY DATE WHICH WAS ON (B)(6) 2013.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINED OF DIFFUSE LAMELLAR KERATITIS (DLK) ON 4 PATIENTS DURING FIELD SERVICE ENGINEER (FSE) VISIT ON (B)(6) 2013. CUSTOMER STATED DLK OBSERVED AT 1 DAY POST-OP ON 4 PATIENTS ON (B)(6) 2013. PATIENT HAD STAGE 1 DLK ON THE BOTH EYES (OU). DATE OF SURGERY WAS ON (B)(6) 2013, AND 15 PATIENTS WERE TREATED ON THAT DAY. DLK RESOLVED ON ALL 4 PATIENTS ON (B)(6) 2013. ALL PATIENTS USED GENERIC BRAND STEROID EYE DROPS, PREDNISOLONE ACETATEEVERY HOUR FOR FIRST 24 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48183 INTRALASE FS2 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20005D

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other