BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 2161817 · Received July 8, 2011

    Report

    Report Number
    2028159-2011-00764
    Event Type
    Injury
    Date Received
    July 8, 2011
    Report Date
    June 9, 2011
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K021566
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE HAS BEEN RECEIVED FOR EVALUATION. 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 HAVING TWO PATIENTS WHO EXPERIENCED TOXIC ANTERIOR SEGMENT SYNDROME (TASS) FOLLOWING AN OCULAR PROCEDURE. THE PHACO TIPS USED DURING THE PROCEDURE WERE NOTED DISCOLORED AFTER THE SURGERY, AND THE FACILITY BELIEVES THIS MAY BE A CONTRIBUTING FACTOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THIS IS THE SECOND OF TWO MEDICAL DEVICE REPORTS FOR THIS FACILITY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention TURBOSONIC FLARED ABS TIP