BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 2201121 · Received July 29, 2011

    Report

    Report Number
    2028159-2011-00883
    Event Type
    Malfunction
    Date Received
    July 29, 2011
    Report Date
    June 29, 2011
    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
    MA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY DID NOT REQUEST SERVICE, HOWEVER A REPLACEMENT FOOTSWITCH WAS ORDERED. THE FOOTSWITCH WAS RECEIVED AND A VISUAL ASSESSMENT OF THE RETURNED FOOTSWITCH DID NOT REVEAL ANY NONCONFORMITY. THE FOOTSWITCH WAS TESTED AND PASSED ALL TESTING. THEREFORE, THE CUSTOMER REPORTED NONCONFORMING FOOTSWITCH DUE TO THE BUTTONS STICKING COULD NOT BE REPLICATED OR CONFIRMED. A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS DID NOT INDICATE ANY ADDITIONAL SIMILAR REPORTS FOR THIS FOOTSWITCH OR SYSTEM. THE ROOT CAUSE IS UNK. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT DURING SURGERY, THERE WERE PROBLEMS WITH THE FOOTSWITCH. THE FOOTSWITCH WAS EXCHANGED AND THE SURGERY WAS COMPLETED. THERE WAS NO IMPACT TO THE PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK INFINITI ENHANCED FOOTSWITCH