BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 1963351 · Received January 14, 2011

    Report

    Report Number
    2028159-2011-00008
    Event Type
    Injury
    Date Received
    January 14, 2011
    Report Date
    December 15, 2010
    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
    ME, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVAL: THE FACILITY DID NOT REQUEST SVC. THERE WAS NO SAMPLE RETURNED FOR EVAL. ROOT CAUSE: A ROOT CAUSE HAS NOT BEEN IDENTIFIED. THE ROOT CAUSE WILL BE REASSESSED UPON COMPLETING THE INVESTIGATION. CORNEAL BURN IS AN ISSUE THAT IS OCCASIONALLY REPORTED WITH CATARACT SURGERY. ACCORDING TO THE ECRI HEALTH DEVICES, HAZARD UPDATE: SCLERAL AND CORNEAL BURNS DURING PHACOEMULSIFICATION, NOVEMBER 1996, VOL. 25, NO. 11: 426-431, 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 CUSTOMER REPORTED DURING AN INTRAOCULAR LENS IMPLANT PROCEDURE, AN ISSUE WITH ASPIRATION OCCURRED RESULTING IN THE PT EXPERIENCING A CORNEAL BURN. THE TIP OF THE HANDPIECE WAS EXCHANGED TO CONCLUDE THE PROCEDURE. IN A F/U, THE SURGEON INDICATED THERE WAS NO PT INJURY AND THE PROGNOSIS WAS GOOD.

    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 Other