BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 3083610 · Received April 29, 2013

    Report

    Report Number
    3006695864-2013-00139
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    March 30, 2013
    Report Date
    March 30, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: AMO'S CLINICAL DEVELOPMENT MANAGER (CDM) VISITED THE SITE ON (B)(4) 2013. THE SITE HAD TRIED LATEX-FREE GLOVES, BUT SWITCHED BACK TO LATEX BECAUSE IT MADE A DIFFERENCE IN THE INCIDENCES OF DLK. THEY HAD CHANGED FROM FILTERED WATER TO STERILE WATER FOR CLEANING AND RINSING INSTRUMENTS, BUT STILL USED FILTERED WATER IN THE STATIM. THEY USED A LONG (WRAPPED) STATIM CYCLE FOR THE FIRST CYCLE OF THE DAY AND THEN UNWRAPPED FOR THE REMAINDER. THE CDM GELLED THE INTRALASE AND FOUND A 35% MELT WITH THEIR CURRENT SETTINGS, SHE MADE CHANGES TO THEIR SETTINGS. THE FLAPS LIFTED EASILY WITH A ONE SWIPE LIFT. THERE WAS NO OPAQUE BUBBLE LAYER (OBL) AND THE DOCTOR WAS PLEASED WITH THE CURRENT LIFTS. NO OTHER OBSERVATIONS WERE MADE BY THE CDM TO EXPLAIN THE DLK AT THIS SITE. ADDITIONAL NARRATIVE- THE EVENT DID NOT REQUIRE SURGICAL/MEDICAL INTERVENTION TO PREVENT FURTHER DAMAGE, A FLAP LIFT AND RINSE/REFLOAT HAD NOT BEEN PERFORMED, AND THERE WAS NO LOSS OF VISION. IT TOOK 3-7 DAYS FOR THE DLK TO RESOLVE. PATIENTS TREATED ON (B)(6) 2013 HAD NO DLK.

    Description of Event or Problem · 1

    CUSTOMER REPORTED 3 PATIENTS WITH DLK WHO WERE TREATED ON (B)(6) 2013. PATIENT HAD TRACE DIFFUSE LAMELLAR KERATITIS (DLK) ON THE RIGHT EYE. THE PATIENT WAS TREATED WITH A STEROID (PREDFORTE). A FLAP LIFT AND RINSE WAS NOT PERFORMED. SURGEON INCREASED THE PREDFORTE, FOLLOWED BY SCHEDULED TAPER. THE PATIENT DID NOT EXPERIENCE A LOSS OF BEST CORRECTED VISUAL ACUITY (BCVA). THE PATIENT WAS ASYMPTOMATIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185281 INTRALASE FS2 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20005D

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Other