BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 2100604 · Received May 13, 2011

    Report

    Report Number
    2028159-2011-00541
    Event Type
    Malfunction
    Date Received
    May 13, 2011
    Date of Event
    April 14, 2011
    Report Date
    April 14, 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
    LA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT PRODUCT REFERENCED IN THE QUESTIONNAIRE (B)(4) IS NOT MFG BY THIS COMPANY. A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS DID NOT INDICATE ANY ADD'L SIMILAR REPORTS FOR THIS SYSTEM. THE TERRITORY MANAGER (TM) CHECKED THE SYSTEM. A SERVICE TEST PROCEDURE WAS PERFORMED AND THE SYSTEM MET SPEC. THE REPORTED EVENT "LOST VACUUM DURING I/A" WAS NOT CONFIRMED BASED ON THE FUNCTIONAL TESTING CONDUCTED BY THE TM. THERE WAS NO SAMPLE RETURNED FOR EVAL, THEREFORE, EVAL STEPS COULD NOT BE TAKEN TO REPLICATE OR CONFIRM THE REPORTED EVENT, AND THE ROOT CAUSE IS UNK. (B)(4).

    Description of Event or Problem · 1

    A HOSP REP REPORTED THAT THE UNIT LOST VACUUM DURING SURGERY. ADD'L INFO PROVIDED VIA COMPLETED QUESTIONNAIRE INDICATES THAT THE EVENT OCCURRED DURING THE IRRIGATION AND ASPIRATION (I&A) OF THE CORTEX. THE CASE WAS COMPLETED AT LOW VACUUM, WHICH TOOK LONGER THAN USUAL. THERE WAS CONTINUOUS INSTABILITY DURING THE CASE, BUT IT WAS REPORTED THAT THERE WAS NO HARM TO THE PT, AND THE INTRAOCULAR LENS (IOL) WAS IMPLANTED.

    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 53 YR DUOVISC