BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRALASE FS2

    MDR report key: 5810888 · Received July 20, 2016

    Report

    Report Number
    3006695864-2016-00729
    Event Type
    Malfunction
    Date Received
    July 20, 2016
    Date of Event
    June 22, 2016
    Report Date
    September 21, 2016
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE RECORDS RELATED TO THIS EQUIPMENT THAT INCLUDED LABELING, MANUAL, TRENDING, AND RISK DOCUMENTATION REVIEWS FOR THIS EQUIPMENT WERE PERFORMED. EQUIPMENT LABELING PROVIDES POSSIBLE COMPLICATIONS THAT CAN BE CAUSED BY THE SURGICAL/TREATMENT PROCEDURE BEING PERFORMED. THE TREND REVIEW SHOWS THAT THERE IS NOT SIGNIFICANT CHANGE OVER HISTORICAL COMPLAINT LIMITS AND NO RECOGNIZABLE ADVERSE TREND. BASED ON THE INVESTIGATION AN ELECTRICAL PROBLEM WAS IDENTIFIED. THERE WAS NO PRODUCT DEFICIENCY FOUND. CUSTOMER REPLACED AC POWER CABLE TO THE UPS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ABBOTT FIELD SERVICE SPECIALIST (FSS) VISITED THE ACCOUNT AND NOTICED UPS AC POWER CORD HAD BAD CONNECTION AND DISCOLORED CONNECTOR WHERE IT GOES INTO THE UPS. DISCOLORATION COULD HAVE BEEN AS A RESULT OF OVERHEATING. SYSTEM MEETS AMO SPECIFICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    ACCOUNT REPORTED UNINTERRUPTIBLE POWER SUPPLY (UPS) BEEPING. CUSTOMER SILENCED THE UPS BY RESETTING THE POWER ON IT AND CONNECTED LASER SYSTEM DIRECTLY TO THE WALL PLUG FOR ONE INLAY PROCEDURE. DURING VISIT OF ABBOTT FIELD SERVICE SPECIALIST (FSS) HE NOTICED DISCOLORATION ON ONE SIDE OF THE CONNECTOR OF THE AC POWER CORD THAT COULD HAVE BEEN AS A RESULT OF OVERHEATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464034 INTRALASE FS2 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20003D

    Patients

    Seq Age Sex Outcome Treatment
    1