BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 3133023 · Received May 29, 2013

    Report

    Report Number
    3006695864-2013-00185
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    April 28, 2013
    Report Date
    April 30, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: ALL PERTINENT INFORMATION AVAILABLE TO AMO AT THE TIME OF THIS REPORT HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    AMO'S CLINICAL DEVELOPMENT MANAGER TALKED WITH THE PHYSICIAN WHO FEELS IT IS NOT RELATED TO THE INTRALASE SYSTEM BUT STATES HE IS UNSURE WHAT THE CAUSE IS. NO CHANGES HAVE BEEN MADE AND NO NEW DROP REGIMEN. CDM DISCUSSED CLEANING REGIMEN WITH TECHNICIANS FROM THE SITE AND RECOMMENDED CHANGING GLOVES AFTER CLEANING INSTRUMENTS AND BEFORE GRABBING STERILE INSTRUMENTS. ALSO RECOMMENDED CHANGING WATER BETWEEN PATIENTS WHEN CLEANING INSTRUMENTS. CDM ALSO DISCUSSED WITH THE MANAGER, HAVING FILTERS IN VENT SYSTEM CHANGED OUT. PHYSICIAN ALSO SPOKE TO TECHNICIANS ABOUT CHANGING FILTERS AND CLEANING HUMIDIFIERS IN SURGICAL SUITE WHILE CDM WAS AT THE OFFICE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED TWO CASES OF DIFFUSE LAMELLAR KERATITIS (DLK) WHO WERE TREATED ON (B)(6) 2013. PATIENT WITH STAGE 1 DLK ON THE RIGHT EYE. PATIENT WAS PRESCRIBED WITH PREDFORTE. NO LOSS OF BEST CORRECTED VISUAL ACUITY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235119 INTRALASE FS2 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20005D

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other