BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 3905986 · Received May 21, 2014

    Report

    Report Number
    2028159-2014-00936
    Event Type
    Injury
    Date Received
    May 21, 2014
    Date of Event
    January 1, 2014
    Report Date
    April 24, 2014
    Manufacturer
    ALCON - IRVINE TECH 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 INFORMATION 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 (B)(6). ALL PATIENTS HAVE RECOVERED AND DONE WELL WITH TREATMENT. THIS FILE IS FOR PATIENT #4 WHO PRESENTED WITH TASS SYMPTOMS. THE PATIENT WAS REFERRED TO A RETINAL SPECIALIST AS THE SURGEON SUSPECTED ENDOPHTHALMITIS BUT ENDED UP THAT IT WAS TASS. THE IS THE FOURTH OF FIVE REPORTS FOR THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303522 INFINITI VISION SYSTEM PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECH CTR INFINITI NA

    Patients

    Seq Age Sex Outcome Treatment
    1