BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 1990876 · Received February 10, 2011

    Report

    Report Number
    2028159-2011-00085
    Event Type
    Injury
    Date Received
    February 10, 2011
    Date of Event
    January 7, 2011
    Report Date
    January 10, 2011
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K082845
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO FIELD SERVICE WAS REQUESTED AND NO SAMPLES ARE EXPECTED TO RETURN FOR IN-HOUSE EVALUATION. A ROOT CAUSE HAS NOT BEEN IDENTIFIED. CORNEAL BURN IS AN ISSUE THAT IS OCCASIONALLY REPORTED WITH CATARACT SURGERY. ACCORDING TO THE (B)(6) PT SAFETY ADVISORY ABSTRACT: PREVENTING CORNEAL BURNS DURING PHACOEMULSIFICATION, MARCH 2010, VOL. 7, NO. 1: 23-25, MOST CORNEAL BURNS CAN BE TRACED TO ISSUES RELATED TO SURGICAL TECHNIQUE AND NOT TO MALFUNCTIONING EQUIPMENT. A LETTER AND COPY OF THIS INDUSTRY ARTICLE WAS PROVIDED TO THE CUSTOMER. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A CORNEAL BURN OCCURRED AT THE END OF THE PHACOEMULSIFICATION PHASE OF A MODEST NUCLEUS EXTRACTION PROCEDURE. A SMALL WHITE PATCH WAS OBSERVED AT THE PROXIMAL SIDE OF THE INCISION THAT MADE CLOSURE VERY DIFFICULT. TWO SUTURES WERE REQUIRED. IN A FOLLOW UP, THE SURGEON REPORTED THE PHACO TIME WAS NOT LONG AND THE CHOP PROCEDURE WAS USED. THE PT IS DOING WELL. 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 Required Intervention PROVISC