BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 3013091 · Received March 15, 2013

    Report

    Report Number
    2028159-2013-00354
    Event Type
    Malfunction
    Date Received
    March 15, 2013
    Date of Event
    February 15, 2013
    Report Date
    February 15, 2013
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CTR
    Product Code
    HQC
    PMA / PMN Number
    K101285
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS IN PROGRESS. A SAMPLE HAS BEEN REC'D, BUT HAS NOT YET BEEN EVALUATED. A ROOT CAUSE HAS NOT BEEN IDENTIFIED. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT LARGE VOLUMES OF AIR CAME FROM THE INFUSION CANNULA AND WENT INTO THE ANTERIOR CHAMBER. THE CUSTOMER CLAMPED THE LINE TO COMPLETE THE PROCEDURE WITH NO HARM TO THE PT. IT WAS NOTED THAT THE PT HAD REC'D A SUTURE FIXATED INTRAOCULAR LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110837 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTAITON HQC ALCON - IRVINE TECHNOLOGY CTR TABLETOP-JAPAN NA

    Patients

    Seq Age Sex Outcome Treatment
    1 25+ GAUGE TOTAL PLUS PAK