BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 3481588 · Received November 21, 2013

    Report

    Report Number
    3006695864-2013-00409
    Event Type
    Injury
    Date Received
    November 21, 2013
    Date of Event
    August 9, 2013
    Report Date
    October 30, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HNO
    PMA / PMN Number
    P930016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER SERIOUS (IMPORTANT MEDICAL EVENTS). DEVICE AVAILABLE FOR EVALUATION: YES. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    PMA/510(K) #PMA/501(K) # K060372. PLACEHOLDER.

    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 AMO HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    THE CLINIC REPORTED THAT A LASER VISION CORRECTION PATIENT PRESENTED WITH LIGHT SENSITIVITY (PHOTOPHOBIA) IN BOTH EYES APPROXIMATELY ONE MONTH AFTER A LASER VISION TREATMENT. THE PATIENT'S SYMPTOMS HAVE IMPROVED WITH MEDICATION HOWEVER ARE NOT 100% RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605440 INTRALASE FS2 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20003D

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR