BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 2852407 · Received November 13, 2012

    Report

    Report Number
    2028159-2012-01793
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Report Date
    October 14, 2012
    Manufacturer
    ALCON- IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K021566
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT RETAIN A SAMPLE FOR THIS COMPLAINT REPORT; FUNCTIONAL TESTING COULD NOT BE CONDUCTED. THE ENTITY SPECIFIC TO THIS EVENT IS NOT KNOWN; THEREFORE, CUSTOMER HISTORY COULD NOT BE REVIEWED. AS THE CUSTOMER DID NOT RETAIN THE FINISHED GOODS LOT NUMBER, DEVICE HISTORY RECORD AND LOT HISTORY COULD NOT BE REVIEWED. THE ROOT CAUSE COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A LEAK IN THE CASSETTE OCCURRED DURING SURGERY WHICH CAUSED INSTABILITY IN THE PT'S ANTERIOR CHAMBER. THE CASSETTE HAD BEEN REUSED. THE CASE WAS COMPLETED WITH AN ALTERNATE PACK. THERE WAS NO HARM TO THE PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK INFINITI MULTIPACK BASIC