BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 3843607 · Received March 25, 2014

    Report

    Report Number
    2028159-2014-00419
    Event Type
    Malfunction
    Date Received
    March 25, 2014
    Date of Event
    January 1, 2014
    Report Date
    February 25, 2014
    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
    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 ADDITIONAL REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A SCRUB TECH REPORTED PROBLEMS WITH IOP (INTRAOCULAR PRESSURE) CONTROL DURING A PROCEDURE WHILE USING THEIR STANDARD SETTINGS. THE TECH ALSO REPORTED A LIGHT PIPE THAT DID NOT FIT INTO THE TROCAR. THE PRODUCTS WERE EXCHANGED AND THE PROCEDURE WAS COMPLETED WITH NO IMPACT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174369 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CTR LX NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK PAK| PRIMARY 23 GAUGE 5.0 CPM