BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 3298883 · Received August 20, 2013

    Report

    Report Number
    3006695864-2013-00332
    Event Type
    Injury
    Date Received
    August 20, 2013
    Date of Event
    April 26, 2013
    Report Date
    June 14, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMISSION NUMBER SHOULD BE 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. QUARTERLY PREVENTIVE MAINTENANCE WAS PERFORMED ON THE SYSTEM BY AN AMO FIELD SERVICE REPRESENTATIVE APPROXIMATELY ONE WEEK PRIOR TO THE EVENT AND APPROXIMATELY TWO MONTHS FOLLOWING THE EVENT AND NO ISSUES WERE FOUND WITH THE SYSTEM. ALL PERTINENT INFORMATION AVAILABLE TO AMO HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    THE CLINIC REPORTED THAT A LASER VISION CORRECTION PATIENT WHO UNDERWENT AN UNEVENTFUL ILASIK PROCEDURE PRESENTED WITH PAIN IN THE RIGHT EYE ONE DAY POST OP. THE PATIENT WAS DIAGNOSED WITH STRIAE AND GUTTER IN THE RIGHT EYE. THE PATIENT WAS RETURNED TO THE SURGEON WHO PERFORMED A FLAP LIFT AND SMOOTH. AT A TWO WEEK POST OP VISIT, THE PATIENT'S VISUAL ACUITY WAS 20/20 IN EACH EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401855 INTRALASE FS2 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20003D

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention