BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISTA 40 HANDPIECE

    MDR report key: 374074 · Received January 17, 2002

    Report

    Report Number
    2085033-2002-00001
    Event Type
    Malfunction
    Date Received
    January 17, 2002
    Date of Event
    December 1, 2001
    Report Date
    January 16, 2002
    Manufacturer
    AMERICAN OPTISURGICAL, INC.
    Product Code
    HQC
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FOLLOWING A ROUTINE CATARACT EXTRACTION UTILIZING THE PENTASYS PHACOEMULSIFICATION SYSTEM, METAL FRAGMENTS WERE SEEN IN THE ANTERIOR CHAMBER OF SEVERAL PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISTA 40 HANDPIECE PHACO HANDPIECE HQC AMERICAN OPTISURGICAL, INC. VISTA 40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other| R