BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERIES TEN THOUSAND OCUTOME

    MDR report key: 109820 · Received July 22, 1997

    Report

    Report Number
    2028159-1997-00122
    Event Type
    Injury
    Date Received
    July 22, 1997
    Date of Event
    July 10, 1997
    Report Date
    July 10, 1997
    Manufacturer
    ALCON LABORATORIES, INC.
    Product Code
    HQE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS MAILED IN TO FDA ON: 11/11/1997.

    Description of Event or Problem · 1

    RPTR STATED CORNEAL GRAFT SUBSEQUENTLY PERFORMED AS A RESULT OF EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERIES TEN THOUSAND OCUTOME VITREORETINAL SURGERY SYSTEM HQE ALCON LABORATORIES, INC. STTO UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other