BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 1791451 · Received August 6, 2010

    Report

    Report Number
    2028159-2010-01434
    Event Type
    Malfunction
    Date Received
    August 6, 2010
    Date of Event
    January 1, 2010
    Report Date
    July 8, 2010
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K082845
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPANY REPRESENTATIVE EXAMINED THE SYSTEM AND WAS UNABLE TO DUPLICATE THE REPORTED EVENT. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "NO PATIENT HARM/INJURY." (NO CONSEQUENCES OR IMPACT TO PATIENT). PRODUCT PROBLEM(S): "ASPIRATION WAS OFF." (ASPIRATION ISSUE); "OCCLUSION OCCURRING MORE FREQUENTLY THAN ANTICIPATED." (OCCLUSION WITHIN DEVICE). A NURSE REPORTED DURING A DENSE CATARACT PROCEDURE, THE SURGEON FELT THE ASPIRATION WAS OFF AND THE OCCLUSION WAS MORE FREQUENT THAN ANTICIPATED. THE NURSE ALSO INDICATED THE SURGERIES FOLLOWING RAN NORMAL AND WITHOUT THE PREVIOUS COMPLICATIONS. THE REMOTE WAS ALSO NOTED TO HAVE HAD SOME ISSUES DUE TO HAVING BEEN DROPPED. THERE WAS NO PATIENT INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1