BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 9410477 · Received December 4, 2019

    Report

    Report Number
    2028159-2019-02164
    Event Type
    Malfunction
    Date Received
    December 4, 2019
    Date of Event
    November 1, 2019
    Report Date
    March 10, 2020
    Manufacturer
    ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K120912
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED IN D.10, 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. FOUR OPENED PROBES WERE RECEIVED WITH NO TIP PROTECTORS, IN A PLASTIC BAG, ALONG WITH FIVE UNOPENED PROBES FOR THE REPORT OF DID NOT CUT APPROPRIATELY. SAMPLE # 1 WAS VISUALLY INSPECTED AND FOUND TO BE NON-CONFORMING WITH WHITE FOREIGN MATERIAL ON THE NEEDLE AND PORT FACE, THE NEEDLE SLIGHTLY BENT, AND THE BODY CRACKED. THE SAMPLE WAS THEN FUNCTIONALLY TESTED FOR ACTUATION, ASPIRATION AND CUT AND WAS FOUND TO BE CONFORMING FOR ALL THREE FUNCTIONAL TESTS. SAMPLE # 2 WAS VISUALLY INSPECTED AND FOUND TO BE NON-CONFORMING WITH A BENT NEEDLE AND WHITE FOREIGN MATERIAL ON THE NEEDLE. THE SAMPLE WAS THEN FUNCTIONALLY TESTED FOR ACTUATION, ASPIRATION AND CUT. THE SAMPLE WAS FOUND TO BE CONFORMING FOR ACTUATION AND CUT AND WAS NON-CONFORMING FOR ASPIRATION. SAMPLE #2 WAS THEN DISASSEMBLED AND THE COMPONENTS INSPECTED. NO/MINIMAL WEAR WAS OBSERVED ON THE INNER CUTTER WHEN COMPARED TO THE DEGREE OF WEAR BASED ON CONTINUOUS ACTUATION OF THE PROBE VISUAL STANDARD PHOTOS. THE INNER CUTTER WAS OBSERVED TO BE BENT. GOUGE MARKS WERE OBSERVED AT THE CUTTING EDGE AND A COUPLE OTHER LOCATIONS ALONG THE INNER CUTTER. WEAR MARKS WERE OBSERVED AT MULTIPLE LOCATIONS ALONG THE INNER CUTTER. A SMALL AMOUNT OF FOREIGN MATERIAL WAS OBSERVED ON ONE OF THE O-RINGS AND ONE OF THE SPACERS. A HOLE WAS OBSERVED IN THE EXTENSION/PISTON BOND AND THE EXTENSION/CUTTER BOND WAS OBSERVED TO BE CRACKED. THE O-RINGS, SPACERS, SPRING AND DIAPHRAGM ARE ALL IN TACT. SAMPLE # 3 WAS VISUALLY INSPECTED AND FOUND TO BE NON-CONFORMING WITH A BENT NEEDLE, CRACKED BODY, AND FOREIGN MATERIAL ON THE PORT FACE AND TIP OF THE NEEDLE. THE SAMPLE WAS THEN FUNCTIONALLY TESTED FOR ACTUATION, ASPIRATION AND CUT AND WAS FOUND TO BE CONFORMING FOR ALL THREE FUNCTIONAL TESTS. SAMPLE # 4 WAS VISUALLY INSPECTED AND FOUND TO BE NON-CONFORMING WITH A CRACKED BODY AND FOREIGN MATERIAL ON THE NEEDLE AND IN THE PORT. THE SAMPLE WAS THEN FUNCTIONALLY TESTED FOR ACTUATION, ASPIRATION AND CUT AND WAS FOUND TO BE CONFORMING FOR ALL THREE FUNCTIONAL TESTS. ALL FOUR OPENED SAMPLES WERE FUNCTIONALLY CONFORMING FOR CUT, THEREFORE, THE FIVE UNOPENED SAMPLES WERE NOT EVALUATED. THE COMPLAINT EVALUATION DOES NOT CONFIRM A CUT FAILURE IN ANY OF THE RETURNED FOUR OPENED PROBES. THE EVALUATION INDICATED THAT ONE OF THE RETURNED PROBES (SAMPLE #2) HAD AN ASPIRATION FAILURE. THE MOST LIKELY ROOT CAUSE FOR THE ASPIRATION NON-CONFORMANCE IS FROM THE BENT NEEDLE AND BENT INNER CUTTER. A BENT NEEDLE AND INNER CUTTER CAN IMPEDE OR FULLY OBSTRUCT ASPIRATION FLOW THROUGH THE PROBE. THE EXACT ROOT CAUSE OF THE BENT NEEDLE AND BENT INNER CUTTER CANNOT BE DETERMINED FROM THIS EVALUATION. THE MOST LIKELY ROOT CAUSE IS HANDLING AT ANY POINT AFTER THE PROBE WAS SHIPPED FROM THE MANUFACTURING SITE. THE IMPACT OF THE CRACKED BOND AND THE BOND WITH A HOLE IN IT OBSERVED ON SAMPLE #2 CANNOT BE DETERMINED. THE EVALUATION DID NOT CONFIRM A CUT FAILURE ON ANY OF THE FOUR OPENED SAMPLES AND AN EXACT ROOT CAUSE FOR THE BENT NEEDLE AND THE BENT INNER CUTTER OBSERVED ON SAMPLE #2 WAS NOT DETERMINED FROM THIS EVALUATION, THEREFORE, NO SPECIFIC ACTION WITH REGARD TO THIS COMPLAINT WAS TAKEN. PROBES ARE 100% VISUALLY INSPECTED AND TESTED FOR ACTUATION, ASPIRATION, AND CUT DURING MANUFACTURING. ANY NON-CONFORMANCES FOUND ARE REMOVED FROM THE LOT AND SCRAPPED. COMPLAINTS ARE REVIEWED AND MONITORED AT REGULAR INTERVALS FOR ANY SIGNIFICANT ADVERSE TRENDS. NO ADDITIONAL ACTION IS REQUIRED AT THIS TIME. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED IN 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. A SAMPLE WAS NOT RECEIVED AT THE MANUFACTURING SITE FOR EVALUATION; THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. A PHOTO OF THE PRODUCTS WAS PROVIDED AND HAS BEEN REVIEWED BY THE MANUFACTURING SITE. THE PHOTOS SHOWS FOUR PROBES IN A BAG AND 5 PROBES IN TRAYS LABELED WITH THE REPORTED PRODUCT AND LOT INFORMATION. DETAILS ABOUT THE FUNCTIONALITY OF THE PROBE CANNOT BE SEEN IN THE PROVIDED PHOTOS. A SAMPLE WAS NOT RECEIVED AT THE MANUFACTURING SITE AND THE DEVICE HISTORY RECORD REVIEW OF THE LOT NUMBER PROVIDED INDICATED THE PRODUCT WAS PROCESSED AND RELEASED ACCORDING TO THE PRODUCT¿S ACCEPTABLE CRITERIA, THEREFORE, THE ROOT CAUSE FOR THE CUSTOMER COMPLAINT ISSUE CANNOT BE DETERMINED. THE EXACT ROOT CAUSE FOR THIS COMPLAINT IS UNKNOWN; THEREFORE, SPECIFIC ACTION WITH REGARDS TO THIS COMPLAINT CANNOT BE TAKEN. ALL PROBES ARE 100% VISUALLY INSPECTED AND TESTED FOR ACTUATION, ASPIRATION, AND CUT DURING MANUFACTURING. ANY NON-CONFORMANCES FOUND ARE REMOVED FROM THE LOT AND SCRAPPED. COMPLAINTS ARE REVIEWED AND MONITORED AT REGULAR INTERVALS FOR ANY SIGNIFICANT ADVERSE TRENDS. NO ADDITIONAL ACTION IS REQUIRED AT THIS TIME. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED. THE REPORTER INFORMED THAT ASPIRATION WAS WORKING.

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

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED THAT FOUR VITRECTOMY PROBES WERE NOT CUTTING APPROPRIATELY DURING A CATARACT SURGERY. THE CONDITION OF ASPIRATION IS UNKNOWN. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1208744 INFINITI VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 INFINITI ANTERIOR VITRECTOMY PAK.