BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHACO LEGACY

    MDR report key: 35430 · Received July 3, 1996

    Report

    Report Number
    35430
    Event Type
    Injury
    Date Received
    July 3, 1996
    Date of Event
    April 26, 1996
    Report Date
    May 8, 1996
    Manufacturer
    ALCON SURGICAL, INC.
    Product Code
    HQC
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING CATARACT SURGERY, THE PHYSICIAN WAS USING MEDICAL DEVICE AS WELL AS ANOTHER INSTRUMENT TO MANIPULATE THE LENS. THE TWO INSTRUMENTS CAME IN CONTACT WITH EACH OTHER ON SEVERAL OCCASIONS AND THE PHACO TIP WAS DAMAGED WITH SEVERAL FRAGMENTS LODGED IN THE PT'S EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHACO LEGACY PHACO LEGACY SERIES 20,000 HQC ALCON SURGICAL, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other
    2