BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERIES TWENTY THOUSAND LEGACY

    MDR report key: 129895 · Received October 31, 1997

    Report

    Report Number
    2028159-1997-00180
    Event Type
    Injury
    Date Received
    October 31, 1997
    Date of Event
    September 30, 1997
    Report Date
    October 2, 1997
    Manufacturer
    ALCON LABORATORIES, INC.
    Product Code
    HQE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    H-10: TO DATE HANDPIECE HAS NOT BEEN REC'D FOR EVAL. THIS REPORT WAS MAILED IN TO FDA ON: 11/21/1997.

    Description of Event or Problem · 1

    RPTR NOTED CORNEAL BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERIES TWENTY THOUSAND LEGACY OPHTHALMIC SURGERY SYSTEM HQE ALCON LABORATORIES, INC. STTL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other