BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR S4 IR EXCIMER LASER

    MDR report key: 3250499 · Received July 26, 2013

    Report

    Report Number
    3006695864-2013-00295
    Event Type
    Injury
    Date Received
    July 26, 2013
    Date of Event
    July 26, 2012
    Report Date
    July 2, 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 AMO FIELD SERVICE ENGINEER EVALUATED THE SYSTEM AT THE CUSTOMER LOCATION AND NO ISSUES WERE FOUND THAT RELATED TO THE REPORTED ISSUE. FIELD SERVICE PERFORMED ROUTINE CALIBRATIONS TO OPTIMIZE SETTINGS AND ALIGNMENTS. ALL PERTINENT INFORMATION AVAILABLE TO AMO HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    THE CLINIC REPORTED THAT A LASER VISION CORRECTION PATIENT PRESENTED AT A POST OP EXAM WITH CENTRAL ISLANDS IN EACH EYE FOLLOWING A STANDARD LASIK TREATMENT. THE PATIENT RECEIVED A STANDARD LASIK ENHANCEMENT TREATMENT IN EACH EYE APPROXIMATELY 8 MONTHS FOLLOWING THE ORIGINAL TREATMENTS. THE PATIENT DID NOT HAVE ANY LOSS OF BEST CORRECTED VISUAL ACUITY PRIOR TO THE ENHANCEMENT. FOLLOWING THE ENHANCEMENT AT THE ONE MONTH POST OP EXAM THE PATIENT'S UNCORRECTED VISUAL ACUITY WAS 20/20 IN THE RIGHT EYE AND 20/25 IN THE LEFT EYE. THE PATIENT ALSO WAS EXPERIENCING DRY EYE PRIOR TO THE ENHANCEMENT AND WAS TREATED WITH RESTASIS AND ARTIFICIAL TEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350082 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