BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION SURGICAL PROCEDURE PACK

    MDR report key: 18709170 · Received February 15, 2024

    Report

    Report Number
    1644019-2024-00276
    Event Type
    Malfunction
    Date Received
    February 15, 2024
    Date of Event
    January 22, 2024
    Report Date
    March 12, 2024
    Manufacturer
    ALCON RESEARCH, LLC - HOUSTON
    Product Code
    LRO
    UDI-DI
    00380657531066
    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

    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. THE SETTING VALUE WAS SET TO INFUSION 30 INTRAOCULAR PRESSURE (IOP CONTROL: ON), BUT THE ACTUAL VITREOUS PRESSURE SOMETIMES ROSE ABOVE THE SETTING VALUE OF 30 DURING TRIPLE CASES. THE VERBIAGE ¿TRIPLE CASES,¿ HAS BEEN DETERMINED BY THE CUSTOMER TO REFERENCE THE COMBINED PROCEDURES KNOWN AS: CATARACT EXTRACTION WITH INTRAOCULAR LENS IMPLANT (CE W/ IOL), VITREORETINAL SURGERY (PARS PLANA VITRECTOMY-PPV), AND THEN AN EPIRETINAL MEMBRANE PEEL (ERM). THE SURGEON REPORTED THAT THE EVENT WAS ¿DIFFICULT TO COMPLETE BECAUSE OF THE TIMING OF THE HIGH IOP. HOWEVER, THE ERM PORTION WAS ABLE TO BE COMPLETED AS SCHEDULED. THERE WAS NO ADVISORY OR OTHER ERROR INDICATION. THE ACTUAL VITREOUS PRESSURE WAS SOMETIMES INCREASED TO 60-70 ACCORDING TO THE PRIMARY SURGEON'S OPINION. THE INFUSION WAS SOMETIMES INCREASED TO A MAXIMUM OF 77 ON THE CONSOLE SCREEN. LOWERING THE INFUSION SETTING TO 20 OR 5 DID NOT RESOLVE THE PROBLEM. THE INCREASED VITREOUS PRESSURE PREVENTED THE ANTERIOR CHAMBER FROM FORMING PROPERLY. THE INTRAOCULAR LENS IMPLANT (IOL) WAS IMPLANTED BEFORE THE VITREOUS PRESSURE ROSE AND WAS ABOUT TO HIT THE CORNEA. THE SURGERY WAS CONTINUED WITH VISCOELASTICS AND MANAGED TO CREATE AN ANTERIOR CHAMBER. THE SURGERY WAS COMPLETED. THE INVOLVED EYE AND THE PATIENT IDENTIFIER ARE NOT AVAILABLE. THERE'S NO PATIENT HARM. THE PROCEDURE TYPE IS UNKNOWN. ADDITIONAL INFORMATION INDICATED THE PATIENTS POST-OPERATIVE VISUAL ACUITY (FIELD) WAS LISTED AS ¿FINE.¿ THE PAK DIRECTIONS FOR USE (DFU) NOTE: THE PROCEDURE PAKS ARE INTENDED FOR ONE PROCEDURE ONLY. REUSE, IMPROPER USAGE OR ASSEMBLY COULD RESULT IN A POTENTIAL HAZARDOUS CONDITION FOR THE PATIENT. THE COMPANY ASSUMES NO RESPONSIBILITY FOR COMPLICATIONS THAT MAY ARISE AS A RESULT OF THE REUSE OR IMPROPER USAGE OF ANY PART OF THE PACK. POTENTIAL RISK FROM REUSE OR REPROCESSING INCLUDE: CONTAMINATION AND SUBSEQUENT EYE INFLAMMATION OR INFECTION, PHOTOTOXICITY FROM INCONSISTENT LASER OR ILLUMINATION EXPOSURE CAUSE BY A DAMAGED FIBER OR CONNECTOR, REDUCED LASER/ILLUMINATION OUTPUT, FLUID PATH LEAKS OR OBSTRUCTION RESULTING IN REDUCED FLUIDICS PERFORMANCE, REDUCED VITREOUS CUTTING PERFORMANCE, REDUCED TIP CUTTING PERFORMANCE, PRESENCE OF TIP BURRS, AND FOREIGN PARTICLE INTRODUCTION INTO THE EYE. THE PHACO TIPS ARE SINGLE USE DEVICES (SUD) AND ARE NOT RECOMMENDED FOR REUSE. PRODUCTION EVALUATION: BASED ON REVIEW OF THE CASSETTE CONFIGURATION, THERE IS NOT AN IRRIGATION FLOW PATH. THE CUSTOMER LIKELY MEANT INFUSION FAILURE. THE RETURNED SAMPLE WAS VISUALLY INSPECTED AND NO OBVIOUS DEFECTS WERE FOUND THAT WOULD CONTRIBUTE TO THE REPORTED EVENT. THE 25 GAUGE G TROCAR CANNULA WAS STILL ON THE INFUSION CANNULA TIP. RESIDUE FROM SURGERY WAS ALSO OBSERVED IN THE ASPIRATION TUBING OF THE PROBE. THE RESIDUE WAS PURGED FROM THE ASPIRATION TUBING TO CONTINUE FUNCTIONAL TESTING. THE NON-INVASIVE FLOW SENSOR (NIFS) ON THE CASSETTE HOUSING WAS IN GOOD CONDITION. A CALIBRATED CONSTELLATION CONSOLE REPRESENTING THE CURRENT SOFTWARE VERSION WAS USED TO TEST THE SAMPLE. THE LIGHT EMITTING DIODE (LED) RINGS ON THE CONSOLE TURNED GREEN AS THE PROBE CONNECTORS WERE ENGAGED TO THE CONSOLE INDICATING THE PROPER COMMUNICATION BETWEEN THE PROBE AND THE CONSOLE. THE BALL IN THE CHECK VALVE OF THE DRIP CHAMBER MOVED FREELY PER SPECIFICATION. THE SAMPLE COULD PRIME AND PASS IOP CALIBRATION SUCCESSFULLY. NO ANOMALIES WERE OBSERVED DURING PRIMING. THE INFUSION PRESSURE WAS MEASURED AT MULTIPLE SET POINTS THROUGHOUT THE CONSOLE RANGE AND MET SPECIFICATIONS. INFUSION FLOW RATE WAS ALSO MEASURED AND MET SPECIFICATIONS. IOP WAS STABLE DURING FUNCTIONAL AND PERFORMANCE TESTING. THE IOP STAYED ACTIVE DURING TEST PROCESS. TOGGLING THE INFUSION AND THE FLUID/AIR EXCHANGE (F/AX) MODES, FLUID AND AIR FLOWED FROM THE CASSETTE TO THE INFUSION LINE CONTINUOUSLY WITHOUT ANY BUBBLE IN VARIOUS SETTINGS IN ALL SUB MODES. WITH THE INFUSION CONTROL ON, FLUID FLOWED FROM THE CASSETTE CONTINUOUSLY WITHOUT GENERATING AIR TO THE INFUSION LINE. WHEN THE FLUID/AIR EXCHANGE (F/AX) CONTROL WAS ON, ONLY AIR WAS INTRODUCED FROM THE CASSETTE TO THE INFUSION LINE. NO SYSTEM MESSAGE CODE WAS GENERATED DURING TESTING. FLUID FLOWED FROM THE 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. CLEANING PROCESS WAS ABLE TO BE PERFORMED AFTER FUNCTIONAL TEST HAD COMPLETED. WE WERE UNABLE TO REPLICATE THE CUSTOMER'S EXPERIENCE DURING LABORATORY EVALUATION. THE ROOT CAUSE OF THE CUSTOMER'S COMPLAINT COULD NOT BE ESTABLISHED; THE RETURNED SAMPLE FUNCTIONED PER SPECIFICATIONS. AFTER INVESTIGATION OF THIS COMPLAINT, IT HAS BEEN DETERMINED THAT THIS SAMPLE FUNCTIONED PER SPECIFICATIONS; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. BASED ON OUR CURRENT TRACKING, THERE ARE NO ADVERSE TRENDS FOR THIS REPORTED COMPLAINT AND LOT. 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).

    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).

    Description of Event or Problem · 0

    A PHYSICIAN REPORTED THAT IRRIGATION FAILURE OCCURRED, VITREOUS PRESSURE ROSE ABOVE THE SETTING VALUE. THE ACTUAL VITREOUS PRESSURE WAS SOMETIMES INCREASED TO 60-70 ACCORDING TO THE PRIMARY SURGEON'S OPINION, AND THE INFUSION WAS SOMETIMES INCREASED TO A MAXIMUM OF 77 ON THE CONSOLE SCREEN. LOWERING THE INFUSION SETTING TO 20 OR 5 DID NOT RESOLVE THE PROBLEM. THE INCREASED VITREOUS PRESSURE PREVENTED THE ANTERIOR CHAMBER FROM FORMING PROPERLY, AND THE INTRAOCULAR LENS (IOL) IMPLANTED IN THE CAT BEFORE THE TRIPLE CASE VITREOUS PRESSURE ROSE WAS ABOUT TO HIT THE CORNEA DURING SURGERY. THE SURGERY WAS CONTINUED WITH VISCOELASTICS AND MANAGED TO CREATE AN ANTERIOR CHAMBER, AND THE SURGERY WAS COMPLETED. THERE WAS NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION WAS PROVIDED INDICATING THAT IT WAS DIFFICULT TO DO BECAUSE OF THE TIMING OF HIGH IOP, BUT PEELING MEMBRANE WAS COMPLETED. POSTOPERATIVELY, THE PATIENT¿S VISION WAS GOOD, HIS VISUAL FIELD WAS FINE, AND THERE WERE NO OTHER WORRISOME RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    798177 CONSTELLATION SURGICAL PROCEDURE PACK GENERAL SURGERY TRAY (KIT) LRO ALCON RESEARCH, LLC - HOUSTON NA 15XL87 00380657531066

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown CONSTELLATION VISION SYSTEM