BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 3905910 · Received May 21, 2014

    Report

    Report Number
    2028159-2014-00939
    Event Type
    Injury
    Date Received
    May 21, 2014
    Date of Event
    January 1, 2014
    Report Date
    April 24, 2014
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CTR
    Product Code
    HQC
    PMA / PMN Number
    K021566
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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

    THE FACILITY REPORTED FIVE CASES OF TOXIC ANTERIOR SEGMENT SYNDROME (TASS) SINCE THE BEGINNING OF EARLY MARCH. ALL PTS HAVE RECOVERED AND DONE WILL WITH TREATMENT. THE FIRST TWO CASES HAPPENED BACK TO BACK (FIFTH AND SIXTH SURGERY CASES OF THE DAY) PERFORMED BY A WELL-ESTABLISHED SURGEON. THEY BOTH RETURNED ONE DAY POST OPERATIVELY WITH TASS SYMPTOMS AND WERE TREATED WITH STEROIDS. THIS FILE IS FOR THE SECOND CASE OF TASS AND SIXTH CASE OF THE SURGICAL DAY. THIS IS THE SECOND OF FIVE REPORTS FOR THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303515 INFINITI VISION SYSTEM PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CTR INFINITI NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention