BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERIES TWENTY THOUSAND LEGACY

    MDR report key: 5329068 · Received September 17, 2004

    Report

    Report Number
    2028159-2004-00210
    Event Type
    Malfunction
    Date Received
    September 17, 2004
    Date of Event
    February 9, 2004
    Report Date
    August 18, 2004
    Manufacturer
    ALCON-IRVINE TECHNOLOGY CENTER
    Product Code
    HQE
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    REPORTER NOTED ONE METALLIC FLECK ON IRIS POST-OP. EYE IS QUIET; PATIENT IS DOING WELL, WITH GOOD VISUAL ACUITY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR