BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERIES TWENTY THOUSAND LEGACY

    MDR report key: 529555 · Received February 26, 2004

    Report

    Report Number
    2028159-2004-00051
    Event Type
    Malfunction
    Date Received
    February 26, 2004
    Date of Event
    January 27, 2004
    Report Date
    January 27, 2004
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    NO ASPIRATION OR VACUUM AT BEGINNING OF PHACO. WITHDREW TIP AND NOTICED A CORNEAL BURN. NO INTERVENTION REQUIRED. PROGNOSIS REPORTED AS GOOD. VA: 20/25.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other