BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERIES TWENTY THOUSAND LEGACY

    MDR report key: 229497 · Received June 23, 1999

    Report

    Report Number
    2028159-1999-00184
    Event Type
    Malfunction
    Date Received
    June 23, 1999
    Date of Event
    May 13, 1999
    Report Date
    May 27, 1999
    Manufacturer
    ALCON LABORATORIES, INC.
    Product Code
    HQE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    RPTR NOTED PARTICLES COMING FROM HANDPIECE DURING PHACO. CHANGED HANDPIECES AND IRRIGATED PARTICLES OUT, COMPLETED CASE AS PLANNED. PARTICLES DETECTED ON IRIS POST-OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERIES TWENTY THOUSAND LEGACY OPHTHALMIC SURGERY SYSTEM HQE ALCON LABORATORIES, INC. STTL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR