BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERIES TWENTY THOUSAND LEGACY

    MDR report key: 461922 · Received May 22, 2003

    Report

    Report Number
    2028159-2003-00104
    Event Type
    Injury
    Date Received
    May 22, 2003
    Date of Event
    April 9, 2003
    Report Date
    April 10, 2003
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER NOTED TWO CORNEAL BURNS OCCURRED WITH THIS UNIT. NO IRRIGATING WELL THROUGH TIP. PATIENT 2 OF 2: STATUS UNKNOWN.

    Description of Event or Problem · 1

    ADDITIONAL INFO RECEIVED 05/2003. PT 2 OF 2: SUTURED WOUND TO CLOSE. PROGNOSIS REPORTED AS GOOD.

    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 67 YR Required Intervention