BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 1001543 · Received February 21, 2008

    Report

    Report Number
    1644019-2008-00002
    Event Type
    Injury
    Date Received
    February 21, 2008
    Date of Event
    January 10, 2008
    Report Date
    January 22, 2008
    Manufacturer
    ALCON -IRVINE TECHNOLOGY CENTER
    Product Code
    HQE
    PMA / PMN Number
    K021566
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED WHEN ADDITIONAL REPORTABLE INFO BECOMES AVAILABLE. THIS REPORT MAILED IN TO FDA ON: 02/21/2008.

    Description of Event or Problem · 1

    THE OPHTHALMOLOGIST PREPARED THE DEVICE FOR SURGERY AND COMPLETED THE SET-UP WITHOUT PROBLEM. THE FIRST CASE WAS COMPLETED WITHOUT A PROBLEM. DURING THE SECOND CASE, WITH THE SAME CASSETTE, THE IRRIGATION WAS DEFECTIVE (A SMALL QUANTITY OF IRRIGATION, AND IRRIGATION ALMOST STOPPED AT THE END OF THE PROCEDURE). THE ANTERIOR CHAMBER COLLAPSED. THE PROCEDURE WAS COMPLETED. CORNEAL EDEMA WAS NOTED ONE DAY POST-OP. THE SURGEON BELIEVES THE OUTCOME WAS DUE TO THE LENGTH OF THE SURGERY. ADD'L INFO RECEIVED ON 02/08/2008 STATED THAT THE PT WAS HOSPITALIZED THREE DAYS IN 2008. THE PROCEDURE WAS CONVERTED TO ECCE, BECAUSE THEY WERE UNABLE TO PERFORM PHACOEMULSIFICATION. THE EVENT OCCURRED DURING THE RE-USE OF A SINGLE USE DEVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization