BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 2051358 · Received April 7, 2011

    Report

    Report Number
    2028159-2011-00333
    Event Type
    Injury
    Date Received
    April 7, 2011
    Date of Event
    March 8, 2011
    Report Date
    March 8, 2011
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K082845
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP EXAMINED THE SYSTEM, CONFIRMED THE SYSTEM MESSAGE IN THE SYSTEM EVENT LOG, HOWEVER, WAS UNABLE TO DUPLICATE THE REPORTED EVENT. THE COMPANY REP REPLACED THE FLUIDICS MODULE, THEN TESTED THE SYSTEM AND FOUND IT MET ALL PRODUCT SPECIFICATIONS. THE REPLACED FLUIDICS MODULE WAS RETURNED FOR EVALUATION. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFO BECOMES AVAILABLE. (B)(4). THIS REPORT WAS MAILED TO FDA ON: 04/07/2011. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL RISK MANAGER REPORTED THAT DURING SURGERY, A SYSTEM MESSAGE WAS DISPLAYED AND THEY EXPERIENCED DECREASED IRRIGATION, INCREASED VACUUM, AND A RETINAL DETACHMENT MAY HAVE OCCURRED AS A RESULT. ADDITIONAL INFO RECEIVED INDICATES THAT RETINAL DETACHMENT IS NOT SUSPECTED, BUT THAT THERE WAS POSSIBLE ZONULAR DEHISCENCE FROM TISSUE AND IRIS CAPTURE. ADDITIONAL 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 84 YR Required Intervention AMVISC