BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 3042916 · Received March 5, 2013

    Report

    Report Number
    2028159-2013-00380
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 15, 2013
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CTR
    Product Code
    HQC
    PMA / PMN Number
    K082845
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP EXAMINED THE SYS AND COULD NOT REPLICATE THE PROBLEM REPORTED. THE COMPANY REP COMPLETED A FOOTSWITCH FUNCTIONAL TEST WITH NO ISSUE OBSERVED. THE SYS WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATION. A REVIEW OF THE SYS EVENT LOG DID NOT REVEAL ANY SYS MESSAGE OR UNUSUAL EVENT WAS CAPTURED ON THE DAY OF THE REPORTED EVENT. THERE WAS NO SAMPLE RETURNED FOR EVALUATION AND NO ADDITIONAL INFO PROVIDED RELATED TO THIS EVENT. THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE SYS DID NOT RECOGNIZE THE FOOTSWITCH DURING SURGERY. THE FOOTSWITCH WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED WITH NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94783 INFINITI VISION SYSTEM OZIL PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CTR INFINITI OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 INFINITI ENHANCED FOOTSWITCH