BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR S4 IR EXCIMER LASER

    MDR report key: 3130478 · Received May 24, 2013

    Report

    Report Number
    3006695864-2013-00179
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    April 26, 2013
    Report Date
    April 29, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    LZS
    PMA / PMN Number
    P930016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE AMO FIELD SERVICE ENGINEER INSPECTED THE EXCIMER LASER AT THE CUSTOMER'S LOCATION AND FOUND THE SYSTEM TO BE OPERATING WITHIN THE SPECIFICATION. NO ISSUES WERE FOUND THAT RELATED TO THE REPORT OF OVERCORRECTIONS. WHILE ON SITE THE FIELD SERVICE FOUND THAT THE ROOM'S HUMIDITY WAS AT THE LOWEST END OF THE SPECIFICATION AND ADVISED THE CLINIC STAFF. ALL PERTINENT INFORMATION AVAILABLE TO AMO HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    THE CLINIC REPORTED THAT THEY HAD OVER CORRECTIONS ON A FEW OF THEIR LASER VISION CORRECTION PATIENTS. THE PATIENTS WERE ALL HIGH MYOPIA PATIENTS OF VARIOUS AGES AND THE TREATMENTS WERE CONDUCTED AT DIFFERENT TIMES THROUGH OUT THE DAY. THERE WERE NO ISSUES WITH THEIR LOWER MYOPIA PATIENTS TREATED ON THE SAME DAY. ADDITIONAL INFORMATION REGARDING THE PATIENT'S OUTCOME HAS BEEN REQUESTED HOWEVER THE CLINIC INDICATED THAT THE DOCTOR WAS FINE AND NO LONGER REQUIRED CLINICAL HELP. THE CLINIC DECLINED TO PROVIDE FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231565 STAR S4 IR EXCIMER LASER EXCIMER LASER LZS ABBOTT MEDICAL OPTICS STAR S4 IR

    Patients

    Seq Age Sex Outcome Treatment
    1 Other