BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-LANCE CORNEAL/SCLERAL BLADE

    MDR report key: 49965 · Received November 15, 1996

    Report

    Report Number
    MW1010265
    Event Type
    Malfunction
    Date Received
    November 15, 1996
    Date of Event
    October 29, 1996
    Report Date
    November 1, 1996
    Manufacturer
    ALCON SURGICAL, INC.
    Product Code
    HQS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING VITRECTOMY SURGERY OF LEFT EYE TWO (2) PIECES OF METAL SHAVINGS WERE VISIBLE WITHIN EYE. MAGNET UTILIZED TO REMOVE METAL. NO HARM TO PT EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V-LANCE CORNEAL/SCLERAL BLADE CORNEAL/SCLERAL BLADE 19 GA HQS ALCON SURGICAL, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR