BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STELLARIS 23GA POSTERIOR PACK

    MDR report key: 2831670 · Received November 9, 2012

    Report

    Report Number
    1920664-2012-00216
    Event Type
    Injury
    Date Received
    November 9, 2012
    Date of Event
    October 15, 2012
    Report Date
    October 16, 2012
    Manufacturer
    BAUSCH & LOMB, INC.
    Product Code
    HQC
    PMA / PMN Number
    K101325
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BE RETURNED FOR EVAL. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ANY ADD'L INFO IS RECEIVED.

    Description of Event or Problem · 1

    THE USER FACILITY IN (B)(6) REPORTED DURING A VITRECTOMY PROCEDURE, THE TROCAR CANNULA BROKE INSIDE THE INCISION. THE CANNULA HAD TO BE REMOVED FROM THE PT'S EYE BY ENLARGING THE TWO PARS PLANA INCISIONS. SURGERY WAS DELAYED TWO HOURS. THE PT IS UNDER OBSERVATION AND IS RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STELLARIS 23GA POSTERIOR PACK HQC BAUSCH & LOMB, INC. BL5223 U8392

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention