BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 2080119 · Received April 7, 2011

    Report

    Report Number
    2028159-2011-00337
    Event Type
    Malfunction
    Date Received
    April 7, 2011
    Date of Event
    March 9, 2011
    Report Date
    March 9, 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
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP EXAMINED THE SYSTEM AND COULD NOT DUPLICATE THE REPORTED EVENT. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECS. THERE ARE NO SAMPLES RETURNING FOR EVAL AND NO ADD'L INFO PROVIDED RELATED TO THIS EVENT, THEREFORE STEPS CANNOT BE TAKEN TO REPLICATE OR CONFIRM THE REPORTED EVENT. THE ROOT CAUSE IS UNK. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED LOW VACUUM DURING A CATARACT EXTRACTION PROCEDURE. ADD'L INFO WAS RECEIVED FROM THE NURSE WHO REPORTED DURING THE PROCEDURE, THE MAXIMUM VACUUM OUTPUT DURING THE PROCEDURE WAS 15 AND A STRANGE NOISE WAS HEARD FROM THE SYSTEM WHEN THE SURGEON LET HIS FOOT OFF THE FOOT PEDAL. IT WAS DISCOVERED THAT THE BALANCED SALINE SOLUTION BOTTLE WAS EMPTY. THE BOTTLE WAS EXCHANGED AND THE CASE WAS COMPLETED WITHOUT FURTHER INCIDENT AND NO PT HARM.

    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 74 YR DUOVISC