BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALCON PHACO

    MDR report key: 307332 · Received November 29, 2000

    Report

    Report Number
    307332
    Event Type
    Other
    Date Received
    November 29, 2000
    Date of Event
    September 28, 2000
    Report Date
    October 19, 2000
    Manufacturer
    ALCON LABORATORIES
    Product Code
    HQE
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD CATARACT OF RIGHT EYE. IN 200O, PT HAD PHACOEMULSIFICATION OF CATARACT OF RIGHT EYE WITH INTRAOCULAR LENS IMPLANT. FOLLOWING CATARACT EXTRACTION, THE AMVISC WAS ASPIRATED FROM THE EYE. THE ANTERIOR CHAMBER WAS DEEPENED WITH MIOSTAT. AT THIS POINT, IT WAS NOTICED THERE WERE APPROXIMATELY 6 SHINY, METALLIC MICROSCOPIC-SIZED FOREIGN BODIES ON THE SURFACE OF THE IRIS IN THE VICINITY OF THE CORNEOSCLERAL WOUND. THE SURGEON BELIEVED THEY CAME FROM THE PHACOTIP. FOUR FRAGMENTS WERE REMOVED BUT TWO WERE RETAINED IN THE EYE DESPITE SEVERAL ATTEMPTS TO REMOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALCON PHACO EMULSIFICATION MACHINE HQE ALCON LABORATORIES * *

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other