BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 2172469 · Received June 24, 2011

    Report

    Report Number
    2028159-2011-00724
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Report Date
    May 27, 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
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP EXAMINED THE SYS AND COULD NOT DUPLICATE THE CUSTOMER REPORTED EVENT. THE SYS'S EVENT LOG WAS REVIEWED AND NO SYS MESSAGES WERE FOUND RELATING TO THE REPORTED PROBLEM. THE SYS WAS THEN TESTED AND MET ALL PRODUCT SPECS. THERE WAS NO SAMPLE RETURNED FOR EVAL AND NO ADD'L INFO PROVIDED RELATED TO THIS EVENT. FOR THIS REASON, STEPS COULD NOT BE TAKEN TO REPLICATE OR CONFIRM THE REPORTED EVENT. A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS DID NOT INDICATE ANY ADD'L SIMILAR REPORTS FOR THIS SYS. THE ROOT CAUSE IS UNK AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED DURING A CATARACT EXTRACTION PROCEDURE, THE SURGEON NOTED THE PHACO AND TORSIONAL POWER WAS LOWER THAN EXPECTED. THE HANDPIECE AND CASSETTE WERE EXCHANGED AND THE SYS WAS RECYCLED; HOWEVER, THE ISSUE DID NOT RESOLVE. THE CASE WAS COMPLETED USING THE SAME SYS BUT THERE WAS A DELAY AND THE CASE TOOK LONGER THAN ANTICIPATED. THERE WAS NO INJURY OR 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