BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERIES TEN THOUSAND OCUTOME

    MDR report key: 129890 · Received October 31, 1997

    Report

    Report Number
    2028159-1997-00178
    Event Type
    Injury
    Date Received
    October 31, 1997
    Date of Event
    August 27, 1997
    Report Date
    August 28, 1997
    Manufacturer
    ALCON LABORATORIES, INC.
    Product Code
    HQE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS MAILED IN TO FDA ON: 11/21/1997.

    Description of Event or Problem · 1

    RPTR NOTED SCLERAL BURN WHILE PERFORMING A PARS PLANA LESNSECTOMY. FELT TIP OCCLUDED. REPLACED HANDPIECE AND TIP TO COMPLETE CASE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention