BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYS

    MDR report key: 3915491 · Received February 26, 2014

    Report

    Report Number
    2028159-2014-00306
    Event Type
    Malfunction
    Date Received
    February 26, 2014
    Date of Event
    January 31, 2014
    Report Date
    January 31, 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
    JA
    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. THE INVESTIGATION IS IN PROGRESS. A SAMPLE IS EXPECTED, BUT HAS NOT YET BEEN RECEIVED FOR EVALUATION. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT DURING SURGERY POOR CUTTING OF THE PROBE OCCURRED AND IT INTERMITTENTLY MOVED AND "ACTED UP". THE PROBLEM WAS SOLVED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. NO FURTHER INFORMATION IS EXPECTED FOR THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118652 CONSTELLATION VISION SYS UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CTR LXT-JAPAN NA

    Patients

    Seq Age Sex Outcome Treatment
    1 TPP, 25+ 5.0 CPM VALVED STD