BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION SURGICAL PROCEDURE PAK

    MDR report key: 14316290 · Received May 7, 2022

    Report

    Report Number
    1644019-2022-00343
    Event Type
    Malfunction
    Date Received
    May 7, 2022
    Date of Event
    April 11, 2022
    Report Date
    August 5, 2022
    Manufacturer
    ALCON RESEARCH, LLC - HOUSTON
    Product Code
    LRO
    PMA / PMN Number
    K880961
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED IN D.9., H.3., H.6. AND H.10. A REVIEW OF THE DEVICE HISTORY RECORD TRACEABLE TO THE REPORTED LOT NUMBER INDICATES THAT THE PRODUCT WAS PROCESSED AND RELEASED ACCORDING TO THE PRODUCT¿S ACCEPTANCE CRITERIA. CURRENT TRACKING INDICATES NO ADVERSE TREND FOR THIS LOT FOR THIS EVENT. THE RETURNED SAMPLE WAS VISUALLY INSPECTED AND NO OBVIOUS DEFECTS WERE FOUND. NO OCCLUSION WAS OBSERVED IN THE MANIFOLDS. THE BALL IN THE CHECK VALVE OF THE DRIP CHAMBER MOVED FREELY PER SPECIFICATION. A CALIBRATED CONSTELLATION CONSOLE REPRESENTING THE CURRENT SOFTWARE VERSION WAS USED TO TEST THE SAMPLE. THE SAMPLE COULD PRIME AND TUNE WITH THE ULTRASONIC HANDPIECE SUCCESSFULLY. NO ANOMALIES WERE OBSERVED DURING PRIMING. NO SYSTEM MESSAGE CODE WAS GENERATED DURING TESTING. THE IRRIGATION PRESSURE RATE MET SPECIFICATION. FLUID FLOWED FROM THE BALANCED SALT SOLUTION (BSS) BOTTLE TO THE DRAIN BAG WITHOUT ANY INTERFERING. NO LEAKAGE WAS DETECTED FROM THE PUMP ELASTOMER OR ON THE PUMP AREA OF THE FLUIDICS MODULE. PROCESS WAS ABLE TO BE PERFORMED AFTER FUNCTIONAL TEST HAD COMPLETED. THE ROOT CAUSE OF THE CUSTOMER'S COMPLAINT COULD NOT BE ESTABLISHED; THE RETURNED SAMPLE FUNCTIONED PER SPECIFICATIONS. AFTER AN INVESTIGATION OF THIS COMPLAINT, IT HAS BEEN DETERMINED THAT THIS SAMPLE FUNCTIONED PER SPECIFICATIONS; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. CURRENT TRACKING INDICATES NO ADVERSE TREND FOR THIS LOT FOR THIS EVENT AS THE PRODUCT MET SPECIFICATIONS. CURRENT TRACKING INDICATES NO ADVERSE TREND FOR THIS LOT FOR THIS EVENT AS THE PRODUCT MET SPECIFICATIONS. QUALITY ASSURANCE HAS REVIEWED THIS COMPLAINT AND WILL CONTINUE TO MONITOR DATA FOR EVIDENCE OF ADVERSE TRENDING AND TAKE FURTHER ACTION, AS APPROPRIATE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A PHYSICIAN REPORTED THE BALANCED SALT SOLUTION DID NOT IRRIGATE DURING A CATARACT SURGERY. THE CASSETTE WAS REPLACED AND THE SURGERY WAS COMPLETED. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1206003 CONSTELLATION SURGICAL PROCEDURE PAK GENERAL SURGERY TRAY (KIT) LRO ALCON RESEARCH, LLC - HOUSTON NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown CONSTELLATION VISION SYSTEM