BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 6679913 · Received June 30, 2017

    Report

    Report Number
    3006695864-2017-00450
    Event Type
    Injury
    Date Received
    June 30, 2017
    Date of Event
    May 31, 2017
    Report Date
    June 29, 2017
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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 SURGERY CENTER REPORTED THAT A LASER VISION CORRECTION PATIENT DEVELOPED STRIAE WITH INFLAMMATION SYMPTOMS ON THE LEFT EYE (OS) AT 5 DAY POST OP EXAM. THE PATIENT'S CHIEF COMPLAINT WAS IT WAS OF BLURRY VISION. A FLAP LIFTED AND RINSE WAS PERFORMED TO RESOLVE THE ISSUE. ON A 10 DAY POST OP EXAM, THE PATIENT HAD DEVELOPED A POTENTIAL VIRAL INFECTION AND POSSIBLY EPIDEMIC KERATOCONJUNCTIVITIS (EKC) WAS NOTED. ON THE 10 DAY POST OP EXAM, THE PATIENT COMMENTED ON THE BLURRY VISION STILL PRESENT WITH WHITE SPOTS ON THE EYE AND LIGHT SENSITIVITY. PRE-OP; BEST CORRECTED VISUAL ACUITY (BCVA) FROM (B)(4)/2017: RIGHT EYE PRE-OP 20/20 .00 X -2.50 X 176, LEFT EYE PRE-OP 20/20 .00 X -2.25 X 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463192 INTRALASE FS2 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20003D

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention WAVELIGHT SERIAL NO. (B)(4)