BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTURION SURGICAL PROCEDURE PAK

    MDR report key: 15985096 · Received December 15, 2022

    Report

    Report Number
    1644019-2022-01056
    Event Type
    Malfunction
    Date Received
    December 15, 2022
    Date of Event
    October 17, 2022
    Report Date
    March 16, 2023
    Manufacturer
    ALCON RESEARCH, LLC - HOUSTON
    Product Code
    LRO
    UDI-DI
    10380657522009
    PMA / PMN Number
    K880961
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    NURSE
    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

    ONE OPENED PHACO TIP IN A WRENCH WITHIN A BAG WAS RECEIVED. THE SAMPLE WAS VISUALLY INSPECTED AND FOREIGN MATERIAL WAS OBSERVED IN THE ASPIRATION BYPASS (AB) HOLE OF THE PHACOEMULSIFICATION TIP, THERE WAS WEAR ON THE THREADS AND BACK OF FLANGE CONSISTENT WITH THREADING ON A HANDPIECE. THE PHACOEMULSIFICATION TIP WAS FUNCTIONALLY TESTED AND WAS FOUND TO BE CONFORMING. THE PHACOEMULSIFICATION TIP WAS SENT TO THE PARTICLE LAB FOR ANALYSIS. THE WHITE PARTICLE WAS ANALYZED USING FOURIER-TRANSFORM INFRARED SPECTROSCOPY (FTIR) AND THE LIBRARY OF SPECTRA DID NOT YIELD ANY GOOD MATCHES. THE SCANNING ELECTRON MICROSCOPE (SEM) AND ENERGY DISPERSIVE SPECTROSCOPY (EDS) ANALYSIS WHICH IDENTIFIED THE MATERIAL TO BE CARBON (C), OXYGEN (O), SODIUM (NA), MAGNESIUM (MG), SULFUR (S), CHLORINE (CI), POTASSIUM (K), AND CALCIUM (CA). THE WHITE PARTICLE APPEARS TO BE PRIMARILY SALTS. THE EXACT IDENTITY IS UNKNOWN. A REVIEW OF THE DEVICE HISTORY RECORD TRACEABLE TO THE REPORTED LOT NUMBER, INDICATES THAT THE REPORTED PRODUCT WAS PROCESSED AND RELEASED ACCORDING TO THE REPORTED PRODUCT¿S ACCEPTANCE CRITERIA. THE RETURNED SAMPLE WAS FOUND TO BE VISUALLY AND FUNCTIONALLY CONFORMING, THEREFORE A TIP THAT CAUSED CALIBRATION NOT TO PASS AND AN ERROR OF LOOSE TIP AS DESCRIBED IN THE COMPLAINT WAS NOT CONFIRMED AND A ROOT CAUSE CANNOT BE DETERMINED FOR THE COMPLAINT AS DESCRIBED BY THE CUSTOMER. UNRELATED TO THE REPORTED ISSUE THE COMPLAINT EVALUATION CONFIRMS THE PHACOEMULSIFICATION TIP ASPIRATION BYPASS (AB) HOLE INNER DIAMETER WAS OCCLUDED WITH FOREIGN MATERIAL. THE ELEMENTAL COMPOSITION OF THE FOREIGN MATERIAL SUGGEST TO BE SALTS. SALTS ARE NOT A MATERIAL USED IN THE MANUFACTURING PROCESS OF PHACOEMULSIFICATION TIPS. HOW AND WHEN THE FOREIGN MATERIAL BECAME PRESENT CANNOT BE DETERMINED FROM THIS EVALUATION AND A ROOT CAUSE CANNOT BE DETERMINED FOR THE COMPLAINT AS DESCRIBED BY THE CUSTOMER. THE MOST LIKELY SOURCE OF THE FOREIGN MATERIAL IS FROM SURGICAL MATERIAL. NO ACTION WAS TAKEN AS THE PHACOEMULSIFICATION TIP WAS MANUFACTURED TO SPECIFICATION. NO SPECIFIC ACTION WITH REGARD TO THE FOREIGN MATERIAL WAS TAKEN BECAUSE THE ROOT CAUSE FOR THE COMPLAINT ISSUE CANNOT BE DETERMINED FROM THIS EVALUATION. ALL PHACO TIPS ARE 100% VISUALLY INSPECTED BY TRAINED OPERATORS USING 30X MAGNIFICATION DURING THE MANUFACTURING PROCESS. COMPLAINTS ARE REVIEWED AND MONITORED AT REGULAR INTERVALS FOR ANY SIGNIFICANT ADVERSE TRENDS. NO ADVERSE TRENDS HAVE BEEN OBSERVED ASSOCIATED WITH THE REPORTED PRODUCT AND EVENT. NO ADDITIONAL ACTION IS REQUIRED AT THIS TIME. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A NURSE REPORTED UPON DEPRESSING THE FOOT PEDAL CALIBRATION DID NOT PASS, ERROR MESSAGES WAS DISPLAYED OF LOOSE TIP BEFORE SURGERY. THERE WAS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2438138 CENTURION SURGICAL PROCEDURE PAK GENERAL SURGERY TRAY (KIT) LRO ALCON RESEARCH, LLC - HOUSTON NA 14D00C 10380657522009

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown CENTURION VISION SYSTEM, ACCESSORY, HANDPIECE