BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 6705373 · Received July 12, 2017

    Report

    Report Number
    2028159-2017-02971
    Event Type
    Malfunction
    Date Received
    July 12, 2017
    Date of Event
    June 19, 2017
    Report Date
    October 25, 2017
    Manufacturer
    ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K101285
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    INVESTIGATION, INCLUDING ROOT CAUSE ANALYSIS, IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Additional Manufacturer Narrative · 1

    AS THE CUSTOMER DID NOT RETAIN THE FINISHED GOODS LOT NUMBER, DEVICE HISTORY RECORD AND LOT HISTORY COULD NOT BE REVIEWED. THE USED SAMPLE WAS RETURNED FOR ANALYSIS AND NO OBVIOUS DEFECTS WERE OBSERVED. AN ELASTOMER AIR BURST TEST WAS PERFORMED AND THE SAMPLE FUNCTIONED WITHIN SPECIFICATIONS. UPON FURTHER INSPECTION, IN RETURNED CONDITION, THE CASSETTE DID NOT EXHIBIT ANY EVIDENCE THAT FLUID MAY HAVE LEAKED FROM THE PUMP ELASTOMER. A FULL INTERNAL PRESSURE LEAK TEST WAS THEN CONDUCTED ON THE CASSETTE UTILIZING AN EXTERNAL PRESSURE SOURCE AND NO LEAKAGE WAS DETECTED. A CONSOLE REPRESENTING A CURRENT SOFTWARE VERSION WAS THEN USED TO TEST THE SAMPLE. THE SAMPLE COULD PRIME AND TUNE WITH THE HANDPIECE SUCCESSFULLY. NO ANOMALIES WERE OBSERVED DURING PRIMING. NO SYSTEM MESSAGE CODE WAS GENERATED DURING TESTING. AFTER FUNCTIONAL TESTING NO LEAKAGE WAS DETECTED FROM THE PUMP ELASTOMER OR ON THE PUMP AREA OF THE FLUIDICS MODULE. FURTHERMORE, NO LEAKAGE WAS DETECTED FROM THE MANIFOLDS, CONNECTORS, OR DRAIN PATH BETWEEN THE CONSUMABLE AND CONSOLE. THE PRESENCE OF FLUID LEAKING FROM THE CASSETTE WAS NOT CONFIRMED. AFTER BOTH LEAKAGE AND CONSOLE LABORATORY TESTING, INSPECTION OF THE SAMPLE INDICATED NO SIGNS OF CONTINUED LEAKAGE FROM THE PUMP ELASTOMER OR CASSETTE. FURTHERMORE, THERE WERE NO SIGNS OF FLUID LEAKAGE ONTO THE FLUIDICS CONSOLE DUE TO LEAKAGE FROM THE CASSETTE. THE CASSETTE PASSED FUNCTIONAL AND PERFORMANCE TESTING. AFTER A THOROUGH INVESTIGATION OF THIS COMPLAINT, IT HAS BEEN DETERMINED THAT THIS SAMPLE MET SPECIFICATIONS; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. QUALITY ASSURANCE WILL CONTINUE TO MONITOR CUSTOMER COMPLAINTS VIA THE COMPLAINT REVIEW MEETINGS, AND WILL TAKE ACTION FOR ANY FUTURE OCCURRENCES AS IS DEEMED NECESSARY. (B)(4).

    Description of Event or Problem · 1

    DURING FOLLOW UP, THE FIELD SERVICE ENGINEER REPORTED VISITING THE SITE AND TESTING THE CASSETTE. NO LEAKS WERE OBSERVED AND IT WAS INFORMED THAT THE LEAK MAY HAVE BEEN A CASE THE RED FITTING NOT BEING TIGHT ALLOWING THE LEAK. THERE WERE NO SIGNS OF BALANCED SALT SOLUTION ON THE FLUIDICS MODULE OF THE CONSOLE. DURING FURTHER FOLLOW-UP IT WAS CONFIRMED THAT THE PROCEDURE WAS FINISHED NORMALLY WITH NO ADVERSE EVENTS TO THE CONSOLE OR THE PATIENT.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE CASSETTE LEAKED BALANCED SALT SOLUTION (BSS) FROM THE BACK OF IT ONTO THE CONSOLE. THE PROCEDURE WAS COMPLETED WITH THE SAME CASSETTE. DURING FOLLOW UP, THE FIELD SERVICE ENGINEER REPORTED VISITING THE SITE AND TESTING THE CASSETTE. NO LEAKS WERE OBSERVED AND IT WAS INFORMED THAT THE LEAK MAY HAVE BEEN A CASE THE RED FITTING NOT BEING TIGHT ALLOWING THE LEAK. THERE WERE NO SIGNS OF BALANCED SALT SOLUTION ON THE FLUIDICS MODULE OF THE CONSOLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489125 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER TABLETOP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other