BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR S4 IR EXCIMER LASER

    MDR report key: 3081411 · Received April 26, 2013

    Report

    Report Number
    3006695864-2013-00136
    Event Type
    Injury
    Date Received
    April 26, 2013
    Date of Event
    March 13, 2013
    Report Date
    April 3, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    LZS
    PMA / PMN Number
    P930016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CLINIC IS REPORTING THIS ADVERSE EVENT ONLY AND DOES 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 UNDERWENT A LIFT FLAP ENHANCEMENT ON (B)(6) 2011, IN THE RIGHT EYE AND PRESENTED AT AN ANNUAL EXAM WITH AN EPITHELIAL INGROWTH IN THE RIGHT EYE. THE SURGEON LIFTED THE FLAP AND REMOVED THE EPITHELIAL INGROWTH. THE PATIENT WAS EXAMINED THE NEXT DAY AND NO EPITHELIAL INGROWTH WAS DETECTED AND THE PATIENT'S VISUAL ACUITY IS 20/70 UNCORRECTED. THE PATIENT WAS RETURNED TO THEIR PRIMARY CARE PROVIDER FOR FOLLOW-UP CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182965 STAR S4 IR EXCIMER LASER EXCIMER LASER LZS ABBOTT MEDICAL OPTICS STAR S4 IR

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention