BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 3221805 · Received July 9, 2013

    Report

    Report Number
    2028159-2013-01354
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    May 29, 2013
    Report Date
    June 14, 2013
    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
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A PT EXPERIENCED A CORNEAL BURN. SUTURES WERE USED TO CLOSE THE MAIN WOUND. THE OUTCOME OF THE PT IS NOTED AS "STILL HEALING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312953 INFINITI VISION SYSTEM OZIL PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER INFINITI OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention BALANCED SALT SOLUTION PLUS| ULTRASOUND FMS 0.9MM ABS| HEALON GV| OZIL TORSIONAL PHACO HANDPIECE| VISCOAT