BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 2223889 · Received August 18, 2011

    Report

    Report Number
    2028159-2011-00975
    Event Type
    Injury
    Date Received
    August 18, 2011
    Date of Event
    July 20, 2011
    Report Date
    July 20, 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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY DID NOT REQUEST SERVICE. NO PARTS WERE 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. A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS DID NOT INDICATE ANY ADDITIONAL RELATED REPORTS FOR THIS SYSTEM. THE ROOT CAUSE IS UNK. (B)(4).

    Description of Event or Problem · 1

    A LEAD PRACTITIONER REPORTED THAT FOREIGN BODIES WERE FOUND IN THE EYES OF TWO PTS DURING SURGICAL PROCEDURES. FOR THIS PT, THE FOREIGN BODY WAS DESCRIBED AS CLEAR, HARD MATERIAL LIKE "PERSPEX", NOT BRITTLE LIKE GLASS. THE FOREIGN BODIES WERE LIKE MICROSCOPIC CRYSTALLIZED ATOMS SEEN PRIOR TO PHACO PROCEDURE WHILE USING THE IRRIGATION SETTING ON THE CONSOLE. THE PT WAS TREATED INTRAOPERATIVELY WITH ADDITIONAL ANTIBIOTICS, AND THE EYE WAS FLUSHED WITH A SALINE SOLUTION USING THE HANDPIECE. THE SAME SALINE SOLUTION BAGS WERE USED FOR BOTH PTS AND UNSPECIFIED DOSES OF ADRENALIN WERE ADDED USING UNFILTERED NEEDLES. THE SAME LOT NUMBER OF VISCOELASTIC WAS USED IN BOTH PTS, BUT THE REPORTER DOES NOT BELIEVE THE FOREIGN MATERIAL IS RELATED SINCE THIS WAS USED AFTER THE FOREIGN MATERIAL WAS DISCOVERED. THE PT OUTCOME WAS REPORTED AS GOOD. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THESE EVENTS; THIS REPORT IS FOR THE SECOND PT.

    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 Required Intervention BALANCED SALT SOLUTION| OZIL TORSIONAL PHACO HANDPIECE| CUSTOM PAK| LIDOCAIN 1%| INTRACAMERAL CEFUROXIME| HEALON