BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 2172444 · Received June 24, 2011

    Report

    Report Number
    2028159-2011-00716
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 25, 2011
    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
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO SAMPLE RETURNED FOR EVALUATION AND NO ADDITIONAL INFORMATION PROVIDED RELATED TO THIS EVENT. FOR THIS REASON, STEPS COULD NOT BE TAKEN TO REPLICATE OR CONFIRM THE REPORTED EVENT AND THE ROOT CAUSE IS THEREFORE UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED DURING SURGERY, THEY WERE UNABLE TO GET THE "FULL PHACO POWER SETTING" AND THAT CASSETTE LEAKAGE WAS NOTED. THE SURGEON WAS ABLE TO COMPLETE THE CASE, BUT CANCELED THE REST OF THE PATIENT'S SCHEDULED FOR THE DAY. THERE WAS NO PATIENT IMPACT REPORTED. MULTIPLE ATTEMPTS WERE MADE TO RETRIEVE ADDITIONAL INFORMATION BUT NONE HAS BEEN RECEIVED TO DATE.

    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