BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 7013344 · Received November 9, 2017

    Report

    Report Number
    2028159-2017-04232
    Event Type
    Malfunction
    Date Received
    November 9, 2017
    Date of Event
    October 12, 2017
    Report Date
    February 26, 2018
    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
    LE
    Reporter Occupation
    OTHER

    Narratives

    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 CUSTOMER REPORTED THAT THE PHACO HANDPIECE DID NOT DELIVER ULTRASOUND. THERE WAS NO REPORTED PATIENT HARM. THE PHACO HANDPIECE WAS MANUFACTURED ON JULY 6, 2016. BASED ON QA ASSESSMENT, THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS DID NOT INDICATE ANY ADDITIONAL RELATED REPORTS FOR THIS PHACO HANDPIECE SERIAL NUMBER. THE PHACO HANDPIECE WAS RECEIVED AND A VISUAL ASSESSMENT OF THE RETURNED SAMPLE FOUND NO VISUAL NONCONFORMITY. THE RETURNED PHACO HANDPIECE WAS CONNECTED TO A CALIBRATED VISION SYSTEM. THE HANDPIECE TUNED SUCCESSFULLY; HOWEVER, SYSTEM MESSAGE (SM) - [U/S HP FAILURE - HANDPIECE CURRENT LOW (OPEN CIRCUIT)] DISPLAYED WHEN ATTEMPTING A FIVE MINUTE BURN-IN WITH THE SYSTEM SET AT 100% ULTRASONIC AND TORSIONAL POWER. THE CUSTOMER REPORTED EVENT WAS CONFIRMED THROUGH TESTING WITH SM - [U/S HP FAILURE - HANDPIECE CURRENT LOW (OPEN CIRCUIT)] DISPLAYING DURING TESTING. THE CUSTOMER REQUESTED THE HANDPIECE TO BE RETURNED; THEREFORE, THE HANDPIECE COULD NOT BE DISASSEMBLED TO DETERMINE ROOT CAUSE. THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE HANDPIECE WAS NOT DELIVERING ULTRASOUND DURING A CATARACT WITH INTRAOCULAR LENS (IOL) SURGICAL PROCEDURE. THE HANDPIECE WAS EXCHANGED TO COMPLETE THE PROCEDURE. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795477 INFINITI VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other