BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STELLARIS MICRO INCISION VACUUM PACK

    MDR report key: 2992361 · Received March 1, 2013

    Report

    Report Number
    1920664-2013-00037
    Event Type
    Injury
    Date Received
    March 1, 2013
    Date of Event
    February 7, 2013
    Report Date
    February 7, 2013
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HQC
    PMA / PMN Number
    K063331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THREE COLLECTION CASSETTES WITH TUBING ASSEMBLIES WERE RECEIVED WRAPPED IN PLASTIC BAGS. THE ORIGINAL PACKAGING WAS NOT RETURNED. WE WERE UNABLE TO DETERMINE WHICH OF THE CASSETTES WERE IN USE WHEN THE REPORTED PROBLEMS OCCURRED. VISUAL INSPECTION FOUND FLUID IN THE LINES AND IN THE COLLECTION CASSETTES. THE IN-LINE FILTER IN THE ASPIRATION LINE CONTAINED A SUBSTANCE WITH THE APPEARANCE OF ORGANIC MATERIAL. A FUNCTIONAL TEST WAS PERFORMED USING A STELLARIS PC SYSTEM. ALL THREE ASSEMBLIES WERE SUCCESSFULLY CAPTURED AND RECOGNIZED BY THE SYSTEM. ALL THREE ASSEMBLIES PASSED THE SELF VACUUM TEST, PRIMED AND FUNCTIONED AS REQUIRED. THERE WAS NO INCIDENCE OF LOW OR WEAK IRRIGATION OR ASPIRATION DURING FUNCTIONAL TESTING. THE REPORTED PROBLEM COULD NOT BE CONFIRMED. THE STERILIZATION AND LOT HISTORY RECORDS WERE REVIEWED AND WERE FOUND TO BE ACCEPTABLE. REPORTS 1 OF 2.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM A USER FACILITY IN THE USA STATING THE COLLECTION CASSETTE BECAME BLOCKED DURING SURGERY CAUSING A LOSS OF ASPIRATION. THE COLLECTION CASSETTE WAS REPLACED AND SURGERY CONTINUED UNTIL THE SECOND CASSETTE ALSO BECAME BLOCKED. THE CASSETTE WAS AGAIN REPLACED AND THE SURGERY WAS COMPLETED. THE TIME REQUIRED TO COMPLETE THE PROCEDURE WAS EXTENDED TO OVER ONE HOUR. THE SURGEON NOTED CORNEAL FOLDS IN THE PATIENT'S EYE AND PRESCRIBED AN ANTI-INFLAMMATORY TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89099 STELLARIS MICRO INCISION VACUUM PACK HQC BAUSCH & LOMB U9394

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention STELLARIS EQUIPMENT (BAUSCH + LOMB)