BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 3042161 · Received April 4, 2013

    Report

    Report Number
    2028159-2013-00561
    Event Type
    Injury
    Date Received
    April 4, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 11, 2013
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K101285
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RO
    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

    AN OPHTHALMIC SURGEON REPORTED NOTICING THE CENTRAL RETINAL ARTERY WAS CLOSING WHILE PERFORMING SILICONE OIL EXPLANTS WITH THE IOP (INTRAOCULAR PRESSURE) CONTROL SWITCHED OFF. THE SURGEON STOPPED INFUSION AND DECREASED THE PRESSURE FROM 20 MMHG (MILLIMETERS OF MERCURY) PRESSURE DOWN TO 12 MMHG. WHEN THE PRESSURE WAS DECREASED, THE BLOOD FLOW RETURNED TO NORMAL. WHEN THE INFUSION WAS RE-INITIATED, THE SAME PROBLEM OCCURRED. THE SURGEON TOOK SPECIAL CARE AND PERFORMED THE SURGERY WHILE CONTINUING TO ANALYZE THE POSTERIOR POLE. THE PROCEDURES WERE COMPLETED WITH NO KNOWN PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138160 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CENTER XT NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other COMBINED PAK 25+ 5.0CPM VALVED 0.9