BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 4080690 · Received May 29, 2014

    Report

    Report Number
    2028159-2014-00904
    Event Type
    Injury
    Date Received
    May 29, 2014
    Date of Event
    January 1, 2014
    Report Date
    April 24, 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
    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 ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THE FACILITY HAS HAD 5 CASES OF TOXIC ANTERIOR SEGMENT SYNDROME (TASS) SINCE THE BEGINNING (B)(6) MARCH. ALL PATIENTS HAVE RECOVERED AND DONE WELL WITH TREATMENT. THIS FILE IS FOR PATIENT #3 WHO PRESENTED 1 WEEK AFTER THE FIRST TWO CASES. THE PATIENT WAS REFERRED TO A RETINAL SPECIALIST AS THE SURGEON SUSPECTED ENDOPHTHALMITIS, BUT ENDED UP THAT IT WAS TASS. THIS IS THE THIRD OF FIVE REPORTS FOR THIS FACILITY. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316322 INFINITI VISION SYSTEM PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER INFINITI NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention