BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS3

    MDR report key: 3790960 · Received May 5, 2014

    Report

    Report Number
    3006695864-2014-00260
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    April 4, 2014
    Report Date
    April 10, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CLINIC IS REPORTING THIS ADVERSE EVENT ONLY AND DID NOT REQUEST OR REQUIRE FIELD SERVICE OR CLINICAL SUPPORT. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    THE CLINIC REPORTED THAT PATIENT HAD LASER VISION CORRECTION ON BOTH EYES PRESENTED WITH A SMALL MICROFIBER/HAIR AT FLAP INTERFACE SUPERIOR NASAL CAUSING A MILD LOCALIZED DIFFUSE LAMELLAR KERATITIS (DLK) ONE DAY POST TREATMENT (EYE WITH PROBLEM NOT REPORTED). THE FLAP LIFTED (UNKNOWN EYE) AND MICROFIBER REMOVED AND INFLAMMATORY CELLS IRRIGATED OUT OF THE INTERFACE. THE VISUAL ACUITY SANS CORRECTION (VASC)FOR BOTH THE EYES WAS REPORTED AS 20/20-1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266659 INTRALASE FS3 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20004

    Patients

    Seq Age Sex Outcome Treatment
    1 26 Required Intervention