BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAR

    MDR report key: 4962579 · Received August 3, 2015

    Report

    Report Number
    3006695864-2015-00475
    Event Type
    Malfunction
    Date Received
    August 3, 2015
    Report Date
    July 17, 2015
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    LZS
    PMA / PMN Number
    P930016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF THE EVENT IS UNKNOWN AS IT WAS NOT PROVIDED. THE LASER MACHINE WAS EXAMINED AND TESTED AT THE CUSTOMER LOCATION BY AN AMO FIELD SERVICE SPECIALIST (FSS). THE FSS REPLACED THE MIRROR 3 (M3) DUE TO BALANCE SALT SOLUTION (BSS). THE FSS STATED THE CUSTOMER MAY HAVE LET THE LASER SYSTEM SIT FOR THREE MONTHS WITHOUT USE. THE SURGERY CENTER INDICATED THEY HAD USED MULTIPLE CARDS BECAUSE THE FLUENCE ERROR HAD A RED ERROR. THE FSS PERFORMED A FIELD SERVICE CHECKLIST. THE SYSTEM WAS VERIFIED FOR ALL MODES OF OPERATIONS. THE SYSTEM MET AMO SPECIFICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    THE SURGERY CENTER REPORTED MULTIPLE FLUENCE OUT OF RANGE ERRORS DURING A LASER TREATMENT AS A RESULT THERE WAS AN INTERRUPTION DURING LASER FIRE. THE SURGERY CENTER REFILLED WITH TWO PURGES TO ELIMINATE THE ERRORS BUT WAS UNSUCCESSFUL. FOUR PROCEDURES WERE CANCELLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503316 STAR EXCIMER LASER LZS ABBOTT MEDICAL OPTICS 0030-1479

    Patients

    Seq Age Sex Outcome Treatment
    1