BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTURION VISION SYSTEM, ACCESSORY, ACTIVE SENTRY HANDPIECE

    MDR report key: 19086548 · Received April 11, 2024

    Report

    Report Number
    2028159-2024-00539
    Event Type
    Malfunction
    Date Received
    April 11, 2024
    Date of Event
    March 12, 2024
    Report Date
    August 5, 2024
    Manufacturer
    ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    UDI-DI
    00380657529148
    PMA / PMN Number
    K161794
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    003

    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

    THE PRODUCT UNDER INVESTIGATION IS NOT A SERVICEABLE DEVICE. THEREFORE, A SERVICE RECORD REVIEW WAS NOT PERFORMED. THERE WAS A PHACO HANDPIECE E(HP) RETURNED FOR TESTING. A NON-CONFORMANCE BASED REVIEW OF THE SERIAL NUMBER WAS PERFORMED AND DID NOT REVEAL ANY POTENTIAL CONTRIBUTING FACTORS TO THE REPORTED COMPLAINT. A MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED PRIOR TO PRODUCT RELEASE TO ENSURE THAT THE PRODUCT WAS MANUFACTURED IN COMPLIANCE WITH THE DEVICE MASTER RECORD. BASED ON THE ASSESSMENT, THE PRODUCT MET RELEASE CRITERIA. A REVIEW FOR COMPLAINTS REPORTED AGAINST THIS SERIAL NUMBER WAS PERFORMED. NO SIMILAR COMPLAINTS WERE REPORTED FOR THE PRODUCT SERIAL UNDER INVESTIGATION. THE HP WAS RECEIVED FOR TESTING. A VISUAL ASSESSMENT OF THE RETURNED SAMPLE REVEALED CONNECTOR DISCOLORATION. THE HANDPIECE WAS CONNECTED TO A CALIBRATED RESISTANCE BREAKOUT BOX, WHERE THE INPUT AND OUTPUT IMPEDANCE WERE FOUND TO BE WITHIN SPECIFICATION. A FLOW RATE TEST WAS PERFORMED ON THE IRRIGATION AND ASPIRATION LINES OF THE HANDPIECE WHICH FOUND THE HANDPIECE TO MEET SPECIFICATIONS PER PRODUCT SPECIFICATIONS. THE RETURNED SAMPLE WAS CONNECTED TO A CALIBRATED SYSTEM. THE HANDPIECE TUNED SUCCESSFULLY AND COMPLETED A FIVE-MINUTE BURN-IN TEST WITH THE SYSTEM SET AT 100% ULTRASONIC AND TORSIONAL POWER. THE HANDPIECE WAS FOUND TO MEET SPECIFICATIONS. THEREFORE, THE ROOT CAUSE OF THE REPORTED EVENT IS INCONCLUSIVE. MANUFACTURER 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 CUSTOMER REPORTED THAT DURING CATARACT SURGERY, AN OPHTHALMIC HANDPIECE EXHIBITED NO TUNE AND NO IRRIGATION IN PHACOEMULSIFICATION MODE. THE PROCEDURE COMPLETED BY OPENING ANOTHER HAND PIECE. PATIENT IMPACT WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1406966 CENTURION VISION SYSTEM, ACCESSORY, ACTIVE SENTRY HANDPIECE UNIT, PHACOFRAGMENTATION HQC ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER NA 141P60 00380657529148

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown