BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 1260043 · Received December 10, 2008

    Report

    Report Number
    2028159-2008-00445
    Event Type
    Injury
    Date Received
    December 10, 2008
    Date of Event
    November 10, 2008
    Report Date
    November 10, 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
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY SERVICE REPRESENTATIVE EXAMINED THE SYSTEM AND COULD NOT DUPLICATE THE REPORTED PROBLEM. PREVENTIVE MAINTENANCE WAS PERFORMED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. 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. HOWEVER, A REVIEW OF THE COMPLAINT TRENDS SHOWS THAT THE FREQUENCY REPORTED IS WITHIN KNOWN LEVELS FOR THIS EVENT.

    Description of Event or Problem · 1

    THE INITIAL INFORMATION RECEIVED STATED THERE WAS A PROBLEM WITH THE LAST CASE OF THE DAY. ADDITIONAL INFORMATION RECEIVED IN 2008 STATED THAT AN UNPLANNED VITRECTOMY WAS PERFORMED, AND THE PATIENT WAS DOING WELL. ADDITIONAL INFORMATION RECEIVED ON 11/13/2008 STATED THAT CASE #9 WAS SCHEDULED AS PKE WITH IOL AND TRABECTULECTOMY WITH MITOMYCIN. THE SURGEON SAID HE FELT A SURGE AND A POSTERIOR CAPSULE TEAR OCCURRED; ANTERIOR VITRECTOMY PERFORMED. THE PATIENT WAS NOTED AS HAVING NO INJURIES. THE SURGEON DECLINED TO RELEASE FURTHER INFORMATION.

    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 81 YR Required Intervention| S