BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CENTURION VISION SYSTEM

    MDR report key: 4241128 · Received November 5, 2014

    Report

    Report Number
    2028159-2014-02073
    Event Type
    Injury
    Date Received
    November 5, 2014
    Date of Event
    September 25, 2014
    Report Date
    October 10, 2014
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K121555
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    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 NURSE REPORTED A FEMALE PATIENT PRESENTED WITH TOXIC ANTERIOR SEGMENT SYNDROME (TASS) POSTOPERATIVELY. IT WAS THOUGHT THE PATIENT HAD A CORNEAL ABRASION, BUT WAS VERIFIED TO BE TASS. THE PATIENT'S SYMPTOMS HAVE RESOLVED. THIS IS THE FIRST OF TWO PATIENTS FOR THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712248 CENTURION VISION SYSTEM PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR DUOVISC| OZIL TORSIONAL PHACO HANDPIECE| INTRAOCULAR LIDOCAINE| BETADINE PREP| TIMOPTIC| AMO IOL ZCT 150| BSS| TETRACAINE| VANCOMYCIN