BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 1791626 · Received August 6, 2010

    Report

    Report Number
    2028159-2010-01414
    Event Type
    Malfunction
    Date Received
    August 6, 2010
    Date of Event
    July 7, 2010
    Report Date
    July 7, 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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "NO PT INJURY REPORTED" (NO CONSEQUENCES OR IMPACT TO PT). PRODUCT PROBLEM(S): "POOR PHACO POWER" (NO CODE AVAILABLE). A FACILITY REPORTED THE SYSTEM DID NOT PERFORM PHACOEMULSIFICATION PROPERLY DURING SURGERY. THE TORSIONAL POWER SETTING WAS AT 90% BUT IT WENT ONLY ON 45%. THE FACILITY CHANGED THE TIP, THE HANDPIECE AND THE CASSETTE BUT IT STILL DID NOT FUNCTION PROPERLY. THERE WAS DELAY OF APPROXIMATELY 5 MINUTES WHILE ANOTHER SYSTEM WAS SET UP. THE PROCEDURE WAS COMPLETED WITH THE OTHER SYSTEM AND THERE WAS NO HARM TO THE PT. ADD'L INFO HAS BEEN REQUESTED.

    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