BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 3011182 · Received March 15, 2013

    Report

    Report Number
    2028159-2013-00353
    Event Type
    Injury
    Date Received
    March 15, 2013
    Date of Event
    February 14, 2013
    Report Date
    February 15, 2013
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K101285
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT AIR LEAKED INTO THE EYE, EVEN THOUGH THE SURGEON WAS NOT USING THE AIR/FLUID EXCHANGE, DURING A CATARACT EXTRACTION/VITRECTOMY PROCEDURE. WHEN THE SURGEON TRIED TO REMOVE THE AIR, THE PROBE "SUCKED" THE POSTERIOR CHAMBER CAUSING A POSTERIOR CAPSULE TEAR. THE INTRAOCULAR LENS WAS NOT ABLE TO BE PLACED IN THE BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110877 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CENTER LT-JAPAN NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention 25+ GAUGE TOTAL PLUS PAK 5.0 CPM