BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 6227883 · Received January 6, 2017

    Report

    Report Number
    3006695864-2017-00014
    Event Type
    Injury
    Date Received
    January 6, 2017
    Date of Event
    November 17, 2016
    Report Date
    January 5, 2017
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    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.

    Description of Event or Problem · 1

    THE CLINIC REPORTED THAT A LASER VISION CORRECTION PATIENT HAD SURGERY ON (B)(6) 2016 AND PRESENTED ON (B)(6) 2016 WITH BILATERAL UVEITIS. IT WAS REPORTED THAT SYMPTOMS ARE NOT RESOLVING WITH TREATMENT. SURGEON ALSO REPORTED THAT DUE TO NATURE OF CONDITION AND PRESENTATION IT IS NOT BELIEVED TO BE RELATED TO LASIK. THE TOPICAL STEROID DOSAGE WAS INCREASED AN ORAL STEROID WAS PRESCRIBED (MEDROL DOSE PACK). IT WAS STATED THAT THE PATIENT HAD NO LOSS OF BEST CORRECTED VISUAL ACUITY (BCVA). THE PATIENT COMPLAINED OF RED AND SORE EYES, BLURRED VISION AND DISCOMFORT. PATIENT REPORTED SYMPTOMS ARE NOT INTERFERING WITH DAILY ACTIVITIES. BCVA FROM (B)(6) 2016: RIGHT EYE PRE-OP 20/20 -6.50 X -.25 X 47, LEFT EYE PRE-OP 20/25 -1650 X -.50 X 172. BCVA FROM (B)(6) 2016: RIGHT EYE POST-OP 20/20 .00 X .00 X 90, LEFT EYE POST-OP 20/20 .00 X .00 X 90.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12695 INTRALASE FS2 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20003D

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention WAVELIGHT (B)(4)