BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR S4 IR EXCIMER LASER

    MDR report key: 3140763 · Received May 31, 2013

    Report

    Report Number
    3006695864-2013-00190
    Event Type
    Injury
    Date Received
    May 31, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 10, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    LZS
    PMA / PMN Number
    P930016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    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 PRESENTED WITH CORNEAL ECTASIA IN BOTH EYES APPROXIMATELY 4 YEARS FOLLOWING A LASER ENHANCEMENT TREATMENT. THE PATIENT'S UNCORRECTED VISUAL ACUITY IS 20/40 IN THE RIGHT EYE AND 20/30 IN THE LEFT EYE. THE BEST CORRECTED VISUAL ACUITY IS 20/20 IN EACH EYE. THE PATIENT WAS REFERRED TO A SPECIALIST FOR FOLLOW-UP CARE AND POSSIBLE CROSS LINKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241636 STAR S4 IR EXCIMER LASER EXCIMER LASER LZS ABBOTT MEDICAL OPTICS STAR S4 IR

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other