BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 1153238 · Received September 5, 2008

    Report

    Report Number
    2028159-2008-00325
    Event Type
    Injury
    Date Received
    September 5, 2008
    Report Date
    August 7, 2008
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K021566
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY SERVICE REPRESENTATIVE EXAMINED THE SYSTEM. THE FACILITY REPORTED THEY WERE TRYING TO INSERT THE PROBE ONTO THE BLACK MALE CONNECTOR. THE COMPANY SERVICE REPRESENTATIVE REPLACED THE MALE PNEUMATIC CONNECTOR. THE CHANGE OF THE PNEUMATIC CONNECTOR WAS COMPLETED IN BETWEEN CASES, SO NO FUNCTIONAL CHECK OF THE SYSTEM WAS PERFORMED. A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS DID NOT INDICATE ANY ADDITIONAL REPORTS FOR THIS SYSTEM. A REVIEW OF COMPLAINT TRENDS INDICATES NO ADVERSE TRENDS FOR THE REPORTED COMPLAINT. THE ROOT CAUSE OF THE PATIENT EVENT CANNOT BE DETERMINED IN THIS INVESTIGATION. POSTERIOR CAPSULE TEAR IS AN ISSUE THAT IS OCCASIONALLY REPORTED WITH CATARACT SURGERY. THIS REPORT WAS MAILED TO THE FDA ON: 09/05/2008.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VITRECTOMY PROBE WAS DIFFICULT TO INSERT IN THE SYSTEM PORT. A POSTERIOR CAPSULE TEAR OCCURRED. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER STATED AN UNPLANNED ANTERIOR VITRECTOMY WAS PERFORMED FOR THE POSTERIOR CAPSULE TEAR. THE EVENT WAS NOT TRIGGERED BY ANY PARTICULAR ACTION. NO SYSTEM MESSAGES DISPLAYED. THE CUSTOMER WAS ABLE TO COMPLETE THE CASE WITH NO PATIENT INJURY NOTED. THE PATIENT'S OUTCOME WAS STATED AS GOOD.

    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 78 YR Required Intervention