BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 1063485 · Received June 20, 2008

    Report

    Report Number
    2028159-2008-00232
    Event Type
    Injury
    Date Received
    June 20, 2008
    Report Date
    May 22, 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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY SERVICE REPRESENTATIVE EXAMINED THE SYSTEM AND REPLACED THE FLUIDICS MODULE FOR DIAGNOSTIC PURPOSES. THE SYSTEM WAS TESTED AND MET ALL PRODUCT SPECIFICATIONS. THE COMPANY SALES REPRESENTATIVE REVIEWED ALL THE PARAMETERS AND FOUND THE PARAMETERS WERE WITHIN ALCON SPECIFICATIONS. THE COMPANY SALES REPRESENTATIVE DID SUGGEST TO THE SURGEON TO INCREASE THE BOTTLE HEIGHT FOR MORE INFUSION PRESSURE AND TO INCREASE HIS INCISION SIZE TO 2.75MM RATHER THAN 2.50MM. THE 2.75MM INCISION SIZE IS RECOMMENDED FOR THE 0.9MM FLARED 45 DEGREE TIP THE SURGEON USES. THE SURGEON DID REPORT THAT HE IS SATISFIED AT THIS TIME WITH THE SUGGESTED RECOMMENDATIONS. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. THIS REPORT MAILED IN TO FDA ON: 06/20/2008.

    Description of Event or Problem · 1

    THE SURGEON REPORTED CHAMBER FLUCTUATION WITH POSTERIOR CAPSULE (PC) TEARS OCCURRING. THE SURGEON STATED THE PC TEARS OCCUR ON 30-40% OF THE PATIENTS OPERATED ON. THE SURGEON STATED THE SYSTEM HAS FAILED TO MAINTAIN THE CHAMBER DEPTH. THE ANTERIOR CHAMBER BECOMES SUDDENLY SHALLOW AFTER THE TIP ASPIRATED THE MATERIAL AND LOST OCCLUSION. THE POSTERIOR CAPSULE CAME UP AND ENGAGED THE PHACO TIP LEADING TO POSTERIOR CAPSULE TEAR. THIS REPORT IS FOR ONE PATIENT; FOR ADDITIONAL PATIENTS SEE MFG. REPORT #'S: 2028159-2008-00233; 2028159-2008-00234.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention| S