BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 3962675 · Received July 16, 2014

    Report

    Report Number
    2028159-2014-01340
    Event Type
    Injury
    Date Received
    July 16, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 18, 2014
    Manufacturer
    ALCON- IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K021566
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    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 INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    AN OPHTHALMIC SURGEON REPORTED A PATIENT EXPERIENCED A THERMAL BURN SHORTLY AFTER STARTING ULTRASOUND (US) DURING A CATARACT PROCEDURE. THE CORNEAL INCISION WAS UNABLE TO BE CLOSED, SO THE SURGEON CLOSED IT WITH THREE SUTURES. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415515 INFINITI VISION SYSTEM PHACOFRAGMENTATION SYSTEM HQC ALCON- IRVINE TECHNOLOGY CENTER INFINITI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ASSY SHIP OZIL HANDPIECE INFINITI| ASSY SHIP KIT 0.9MM ULTRA