BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 2963486 · Received February 13, 2013

    Report

    Report Number
    2028159-2013-00188
    Event Type
    Injury
    Date Received
    February 13, 2013
    Date of Event
    January 14, 2013
    Report Date
    January 14, 2013
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE EXAMINED THE SYSTEM AND COULD NOT DUPLICATE THE PROBLEM REPORTED. A FUNCTIONAL EVALUATION OF THE HANDPIECE USED BY THE CUSTOMER WAS PERFORMED AND NO ISSUES WERE OBSERVED AS 600 MILLIMETERS OF MERCURY WAS ACHIEVED CONSISTENTLY. UNRELATED TO THE CUSTOMER REPORTED EVENT, PREVENTIVE MAINTENANCE WAS PERFORMED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS DID NOT INDICATE ANY ADDITIONAL SIMILAR REPORTS FOR THIS SYSTEM. THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. (B)(4).

    Description of Event or Problem · 1

    A SURGICAL TECHNICIAN REPORTED THAT THE VACUUM WAS NOT WORKING (PROPERLY) IN CORTEX MODE DURING PHACOEMULSIFICATION WITH LENS IMPLANT SURGERY WHICH WAS COMPLETED AFTER A 40 MINUTE DELAY. IT WAS FURTHER REPORTED THAT THE PATIENT MAY HAVE RESIDUAL VISCOELASTIC IN THE EYE AND WAS GIVEN A CARBONIC ANHYDRASE INHIBITOR TO KEEP THE INTRAOCULAR PRESSURE DOWN. THE PATIENT DID NOT RETURN (AS SCHEDULED) FOR ADDITIONAL TREATMENT INDICATING TO SURGEON THAT "ALL IS WELL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62360 INFINITI VISION SYSTEM PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER INFINITI NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention