BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINIT VISION SYSTEM

    MDR report key: 1202835 · Received October 17, 2008

    Report

    Report Number
    2028159-2008-00376
    Event Type
    Injury
    Date Received
    October 17, 2008
    Report Date
    September 17, 2008
    Manufacturer
    ALCON-IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K021566
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY SALES REP WENT TO THE FACILITY TO REVIEW THE CLEANING AND STERILIZATION PROCEDURES WITH THE STAFF. THE FACILITY STAFF IS FOLLOWING RECOMMENDED CLEANING AND STERILIZATION PRACTICES. THE ROOT CAUSE OF THE PT EVENT CANNOT BE DETERMINED IN THIS INVESTIGATION. THIS REPORT WAS MAILED TO FDA ON: 10/17/2008.

    Description of Event or Problem · 1

    THE NURSE INITIALLY REPORTED SEVERAL CASES OF ENDOPHTHALMITIS. THIS PT'S VISUAL RECOVERY WAS REPORTED AS SATISFACTORY. ADDITIONAL INFO HAS BEEN REQUESTED, BUT NOT RECEIVED TO DATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other