BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 3251111 · Received July 29, 2013

    Report

    Report Number
    3006695864-2013-00301
    Event Type
    Injury
    Date Received
    July 29, 2013
    Date of Event
    June 27, 2013
    Report Date
    June 27, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    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

    CLINICAL DEVELOPMENT MANAGER (CDM) PERFORMED A DLK INVESTIGATION AND OBSERVED CASES ON (B)(6) 2013. CDM GELLED LASER AND PERFORMED A Z CALIBRATION. THERE WAS NO CHANGE IN INTRALASE SURGICAL SETTINGS. LAST FIELD SERVICE VISIT WAS ON (B)(4) 2013, AND PREVENTATIVE MAINTENANCE (PM) WAS PERFORMED. THERE WERE NO PROBLEMS OR OBSERVATIONS MADE. SYSTEM MEETS ALL AMO SPECIFICATIONS. DLK SEEN ONLY ON (B)64 20)13. NO OTHER DLK INCIDENTS SINCE (B)(6) 2013. CUSTOMER CHANGED OPERATIVE ANTIBIOTIC EYEDROPS PRIOR TO (B)(6) 2013 FROM ZYMAX TO TOBRAMYCIN AND POLYTRIM. CUSTOMER RECENTLY PURCHASED 2ND SCISCAN STATIM. NO OTHER MEDICAL OR SURGICAL CHANGES IN LASER SUITE. NO CHANGE IN STAFF. CUSTOMER UNAWARE OF CAUSE OF DLK. THERE WAS A CLEAN AND STABLE LASER SUITE ROOM ENVIRONMENT WITH CONTROLLED AC/VENTILATION SYSTEM AND MAINTENANCE PERFORMED EVERY 6 MONTHS WITH AIR FILTER CHANGE. CDM DISCUSSED THE FOLLOWING WITH THE CUSTOMER: 1) CHANGING INSTRUMENT CLEANING SOLUTION AND DISTILLED WATER RINSING BOWLS AFTER EACH TO PREVENT CROSS-CONTAMINATION, 2) USING NEW OPERATIVE EYEDROPS EACH SURGERY DAY TO PREVENT CROSS-CONTAMINATION, AND 3) INCREASING PRED FORTE USAGE FROM FOUR TIMES A DAY TO EVERY 2 HOURS POST-OPERATIVELY TO HELP MINIMIZE INCIDENCE OF DLK. CDM DISCUSSED IMPORTANCE OF CHANGING ONE THING AT A TIME TO HELP DISCOVER CAUSE OF DLK. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    (B)(4). PLACEHOLDER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED 4 CASES OF DIFFUSE LAMELLAR KERATITIS (DLK). PATIENT HAD STAGE 1 DLK ON THE LEFT EYE. PATIENT WAS TREATED WITH PRED FORTE. NO FLAP LIFT AND RINSE WAS PERFORMED. ADDITIONAL FOLLOW UP WAS OBTAINED. THE DLK CLEARED ON POST OP CHECK (B)(6) 2013. THERE WAS NO LOSS OF VISION. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352282 INTRALASE FS2 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20003D

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Other