BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR S4 IR EXCIMER LASER

    MDR report key: 3111551 · Received May 14, 2013

    Report

    Report Number
    3006695864-2013-00164
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 16, 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 DID 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 5 1/2 YEARS AFTER THEIR LASER TREATMENT. THE PATIENT'S CORRECTED VISUAL ACUITY WAS 20/40-2 IN THE RIGHT EYE AND 20/50-2 IN THE LEFT EYE. THE PATIENT'S UNCORRECTED VISUAL ACUITY WAS 20/150 IN THE RIGHT EYE AND 20/150 IN THE LEFT EYE. THE PATIENT WAS REFERRED TO A SPECIALIST AND HAS UNDER GONE CROSS LINKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213087 STAR S4 IR EXCIMER LASER EXCIMER LASER LZS ABBOTT MEDICAL OPTICS STAR S4 IR

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention