BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 3232486 · Received July 18, 2013

    Report

    Report Number
    3006695864-2013-00273
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 21, 2013
    Report Date
    June 21, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EQUIPMENT WAS NOT EVALUATED AFTER THE TREATMENT SINCE THERE WAS NO INDICATION THAT A MALFUNCTION CAUSED THE REPORTED ISSUE. THE CLINIC IS REPORTING THIS EVENT ONLY AND DID NOT REQUEST FIELD SERVICE OR CLINICAL SUPPORT. NOTE: ALL PERTINENT INFORMATION AVAILABLE TO AMO AT THE TIME OF THIS REPORT HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    PATIENT WITH TRACE DIFFUSE LAMELLAR KERATITIS (DLK) AT 1 DAY POST OP, SECONDARY TO BANDAGE CONTACT LENS ON BOTH EYES. PATIENT WAS TREATED WITH PREDFORTE. NO FLAP LIFT AND RINSE PERFORMED. PATIENT EXPERIENCED LOSS OF BEST CORRECTED VISUAL ACUITY. UNCORRECTED VISUAL ACUITY (UCVA) WAS 20/30-2 ON THE RIGHT EYE AND 20/25-2 ON THE LEFT EYE. PATIENT FELT BLURRY AND IRRATED EYES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334872 INTRALASE FS2 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20005D

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other