BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WHITESTAR SIGNATURE SYSTEM

    MDR report key: 1931580 · Received December 9, 2010

    Report

    Report Number
    2020664-2010-00135
    Event Type
    Injury
    Date Received
    December 9, 2010
    Date of Event
    November 10, 2010
    Report Date
    November 10, 2010
    Manufacturer
    ABBOTT MEDICAL OPTICS (AMO)
    Product Code
    HQC
    PMA / PMN Number
    K060366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PHACOEMULSIFICATION MACHINE WAS EXAMINED AND TESTED AT THE CUSTOMER LOCATION BY AN AMO SERVICE TECH. DURING INSPECTION OF THE MACHINE, THE TECH FOUND THE FOOT PEDAL CABLE HAD POOR INSULATION AND AS A PROACTIVE MEASURE THE CABLE WAS REPLACED. PER THE TECH, THE FOOT PEDAL CABLE'S POOR INSULATION WAS NOT RELATED TO THE REFLUX ISSUE OR THE REPORTED EVENT. THERE WERE NO ISSUES DETECTED WITH THE OPERATION OF THE MACHINE. THE TECH FOUND THE REFLUX FEATURE WAS WORKING PROPERLY. THE MACHINE WAS FOUND TO MEET AMO SPECS. THE TECH WAS NOT ABLE TO IDENTIFY AN EXPLANATION FOR THE EVENT. THE SYSTEM HAS CONTINUED TO BE USED WITHOUT ANY FURTHER REPORTED INCIDENTS. NO ADD'L INFO WAS PROVIDED.

    Description of Event or Problem · 1

    THE CLINIC REPORTED EXPERIENCING A POSTERIOR CAPSULE TEAR RESULTING IN UNPLANNED VITRECTOMY IN THE PT'S OPERATIVE EYE DURING A CATARACT EXTRACTION PROCEDURE. THE CLINIC REPORTED THE REFLUX MODE WAS NOT FUNCTIONAL WHEN ATTEMPTING TO ACTIVATE THE REFLUX FEATURE CAUSING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WHITESTAR SIGNATURE SYSTEM HQC ABBOTT MEDICAL OPTICS (AMO) NGP680300

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention