BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERIES TWENTY THOUSAND LEGACY

    MDR report key: 707961 · Received April 26, 2006

    Report

    Report Number
    2028159-2006-00135
    Event Type
    Malfunction
    Date Received
    April 26, 2006
    Report Date
    March 28, 2006
    Manufacturer
    ALCON-IRVINE TECHNOLOGY CENTER
    Product Code
    HQE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A REFLUX OF SOME MILKY SUBSTANCE CAME OUT OF U/S HANDPIECE AT START OF PHACO. ASPIRATION STOPPED, RESULTING IN CORNEAL BURNS.

    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 NO INFO