BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 3820129 · Received April 1, 2014

    Report

    Report Number
    2028159-2014-00547
    Event Type
    Malfunction
    Date Received
    April 1, 2014
    Report Date
    March 4, 2014
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K082845
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A SERVICE VISIT HAS BEEN PERFORMED. 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. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED NO TORSIONAL POWER AT THE PHACO TIP DURING CATARACT SURGERY. THE HANDPIECE WAS EXCHANGED, BUT THE ISSUE REMAINED. THE SYSTEM WAS REBOOTED TO COMPLETE THE CASE WITHOUT FURTHER INCIDENT. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196428 INFINITI VISION SYSTEM PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER INFINITI OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK