BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 5963000 · Received September 20, 2016

    Report

    Report Number
    2028159-2016-04265
    Event Type
    Malfunction
    Date Received
    September 20, 2016
    Date of Event
    September 14, 2016
    Report Date
    December 12, 2016
    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
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CALLED THE COMPANY REPRESENTATIVE TO ASSIST WITH TROUBLESHOOTING. THE CUSTOMER DECLINED SERVICING AND PURCHASED A NEW SYSTEM, INSTEAD. THE REQUEST FOR SERVICE WAS SUBSEQUENTLY CANCELLED, AS A RESULT. THE SYSTEM WAS MANUFACTURED ON NOVEMBER 14, 2008. BASED ON QA 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 DOCTOR OF OPHTHALMOLOGY REPORTED THAT THE POWER FELL DOWN DURING A SURGERY. THE SURGERY WAS COMPLETED. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615979 INFINITI VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other