BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOVEREIGN SYSTEM

    MDR report key: 1241748 · Received November 19, 2008

    Report

    Report Number
    2020664-2008-00057
    Event Type
    Injury
    Date Received
    November 19, 2008
    Date of Event
    October 15, 2008
    Report Date
    October 28, 2008
    Manufacturer
    ADVANCED MEDICAL OPTICS (AMO)
    Product Code
    HQC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO PROVIDED BY THE MFR. EVALUATION SUMMARY: THE PHACOEMULSIFICATION MACHINE WAS EXAMINED AND TESTED AT THE CUSTOMER LOCATION BY AN AMO SERVICE TECH. NO ISSUES WERE DETECTED THAT RELATED TO THE INCIDENT, HOWEVER, IT WAS NOTED THAT THE PUMP ASSEMBLY WAS LOOSE DUE TO A MISSING SCREW. EQUIPMENT WAS REPAIRED.

    Description of Event or Problem · 1

    THE SURGEON REPORTED EXPERIENCING A BROKEN CAPSULE IN THE OPERATIVE EYE DURING A PHACOEMULSIFICATION PROCEDURE. A VITRECTOMY WAS PERFORMED AND THE PT WAS IMPLANTED WITH A PC LENS. EIGHT DAYS FOLLOWING THE PROCEDURE, THE PT RETURNED TO SURGERY FOR REPOSITIONING OF THE LENS. THE SURGEON REPORTED THAT THE PUMP WHEEL WAS LOOSE ON THE PHACO MACHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOVEREIGN SYSTEM PHACOEMULSIFICATION SYSTEM HQC ADVANCED MEDICAL OPTICS (AMO) SOV680300 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Other