BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERIES TWENTY THOUSAND LEGACY

    MDR report key: 328314 · Received April 16, 2001

    Report

    Report Number
    2028159-2001-00126
    Event Type
    Malfunction
    Date Received
    April 16, 2001
    Date of Event
    March 16, 2001
    Report Date
    March 21, 2001
    Manufacturer
    ALCON-IRVINE TECHNOLOGY CENTER
    Product Code
    HQE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER NOTED SILVER METALLIC PARTICLES IN EYE; SUSPECTS THEY ENTERED DURING PHACO. SOME PARTICLES REMAIN ON IRIS SURFACE. NO INJURY TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17254 SERIES TWENTY THOUSAND LEGACY OPHTHALMIC SURGERY SYSTEM HQE ALCON-IRVINE TECHNOLOGY CENTER STTL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR