BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 3905891 · Received May 21, 2014

    Report

    Report Number
    2028159-2014-00937
    Event Type
    Injury
    Date Received
    May 21, 2014
    Date of Event
    March 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 INCLUDED 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

    A FACILITY REPORTED FIVE CASES OF TOXIC ANTERIOR SEGMENT SYNDROME (TASS) SINCE THE BEGINNING OF EARLY MARCH. ALL PTS HAVE RECOVERED AND DONE WELL WITH TREATMENT. THIS REPORT IS FOR PT #5: THE FIFTH CASE PRESENTED ONE DAY POST-OPERATIVELY WITH TASS SYMPTOMS. THIS IS THE FINAL OF FIVE REPORTS FOR THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303497 INFINITI VISION SYSTEM PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CTR INFINITI NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention