BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 2230523 · Received August 12, 2011

    Report

    Report Number
    2028159-2011-00952
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    July 14, 2011
    Report Date
    July 15, 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
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY DID NOT REQUEST SERVICE. THERE WAS NO SAMPLE RETURNED FOR EVAL, THEREFORE STEPS COULD NOT BE TAKEN TO REPLICATE OR CONFIRM THE REPORTED EVENT. A ROOT CAUSE HAS NOT BEEN IDENTIFIED. CORNEAL BURN IS AN ISSUE THAT IS OCCASIONALLY REPORTED WITH CATARACT SURGERY. ACCORDING TO (B)(4), MOST CORNEAL BURNS CAN BE TRACED TO ISSUES RELATED TO SURGICAL TECHNIQUE AND NOT TO MFG EQUIPMENT. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED A THERMAL INJURY OCCURRED AT THE INCISION SITE. THE SURGEON THINKS THIS EVENT WAS RELATED TO THE SYSTEM SETTINGS. SUTURES WERE USED TO CLOSE THE WOUND, BUT HAD TO BE REMOVED AND RESUTURED DURING THE INITIAL PROCEDURE. ADD'L INFO WAS 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 45 DEGREE KELMAN MINI-FLARE TIP| DUOVISC| 0.9 MM MICROSMOOTH| 2.2 MM ANGLED SLIT KNIFE| BASIC ULTRASOUND FMS