BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTURION VISION SYSTEM

    MDR report key: 8603175 · Received May 13, 2019

    Report

    Report Number
    2028159-2019-00862
    Event Type
    Malfunction
    Date Received
    May 13, 2019
    Date of Event
    April 15, 2019
    Report Date
    July 23, 2019
    Manufacturer
    ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K121555
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION HAS BEEN PROVIDED: THE PHACOEMULSIFICATION (PHACO) HANDPIECE WAS RECEIVED AND A VISUAL ASSESSMENT OF THE RETURNED SAMPLE FOUND NO VISUAL NONCONFORMITY. A FLOW RATE TEST WAS PERFORMED ON THE IRRIGATION AND ASPIRATION LINES OF THE HANDPIECE, WHICH FOUND THE HANDPIECE TO MEET PRODUCT SPECIFICATIONS. THE RETURNED HANDPIECE WAS CONNECTED TO A CALIBRATED SYSTEM. THE HANDPIECE TUNED SUCCESSFULLY; HOWEVER, SYSTEM MESSAGE (SM) - [U/S HP FAILURE - HANDPIECE VOLTAGE LOW (SHORT CIRCUIT)] DISPLAYED WHEN ATTEMPTING A FIVE MINUTE BURN-IN WITH THE SYSTEM SET AT 100% ULTRASONIC AND TORSIONAL POWER. NO FURTHER FUNCTIONAL TESTING COULD BE PERFORMED FOR TEMPERATURE. DISASSEMBLING THE HANDPIECE REVEALED MOISTURE INGRESS WITHIN THE ELECTRODE CHAMBER. THE TESTING FOUND THE PHACO HANDPIECE TO MEET PRODUCT SPECIFICATIONS FOR ASPIRATION. THEREFORE, THE CUSTOMER REPORTED EVENT OF POOR ASPIRATION/VACUUM COULD NOT BE CONFIRMED. THE CUSTOMER REPORTED EVENT OF A HOT HANDPIECE WAS UNABLE TO BE CONFIRMED, AS THE TEMPERATURE TEST COULD NOT BE PERFORMED DUE TO THE SM [U/S HP FAILURE - HANDPIECE VOLTAGE LOW (SHORT CIRCUIT)] DISPLAYED DURING BURN-IN. THE UNRELATED SM [U/S HP FAILURE - HANDPIECE VOLTAGE LOW (SHORT CIRCUIT)] WAS CAUSED BY MOISTURE INGRESS WITHIN THE ELECTRODE CHAMBER; HOWEVER, HOW OR WHEN MOISTURE ENTERED THE HANDPIECE REMAINS INCONCLUSIVE. THE PHACO HANDPIECE MANUFACTURING DEVICE HISTORY RECORD (DHR) WAS REVIEWED. BASED ON ASSESSMENT, THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    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 CUSTOMER REPORTED THAT THERE WAS INSUFFICIENT VACUUM AND THE HANDPIECE GOT HOT DURING A PROCEDURE. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE HANDPIECE. THERE WAS NO PATIENT CONTACT AND NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399354 CENTURION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1