BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 6189620 · Received December 20, 2016

    Report

    Report Number
    2028159-2016-05851
    Event Type
    Malfunction
    Date Received
    December 20, 2016
    Date of Event
    December 7, 2016
    Report Date
    March 14, 2017
    Manufacturer
    ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K120912
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED FROM THIS CUSTOMER. HOWEVER, THE HANDPIECE WAS RETURNED FOR INVESTIGATION THE PHACOEMULSIFICATION (PHACO) HANDPIECE WAS MANUFACTURED ON DECEMBER 11, 2013. BASED ON QA ASSESSMENT, THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. THE HANDPIECE WAS RECEIVED FOR EVALUATION. A VISUAL ASSESSMENT OF THE RETURNED SAMPLE REVEALED DISCOLORATION OF THE CABLE AND CABLE CONNECTOR. THE HANDPIECE STRAIN RELIEF WAS SHOWING BEGINNING STAGES OF SEPARATION. A FLOW RATE TEST FOUND THE HANDPIECE TO MEET ALCON SPECIFICATIONS. THE HANDPIECE WAS THEN CONNECTED TO A CALIBRATED INFINITI SYSTEM. THE HANDPIECE TUNED SUCCESSFULLY AND COMPLETED A FIVE MINUTE BURN-IN TEST WITH THE SYSTEM SET AT 100% ULTRASONIC AND TORSIONAL POWER. AN ANALYSIS OF DATA SHOWED NO TUNING FAILURES AFTER A TOTAL OF 304 TUNES. THE STROKE TEST FOUND THE HANDPIECE TO MEET ALCON SPECIFICATIONS. THE HANDPIECE WAS FOUND TO MEET SPECIFICATIONS. THEREFORE, THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED CONCLUSIVELY. (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).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A NURSE REPORTED THAT A HANDPIECE PRESENTED WITH NO PHACOEMULSIFICATION DURING A PROCEDURE. THE PROCEDURE WAS COMPLETED AFTER EXCHANGING THE HANDPIECE. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840425 INFINITI VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other OZIL TORSIONAL PHACO HANDPIECE