BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 3221869 · Received July 9, 2013

    Report

    Report Number
    2028159-2013-01338
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 17, 2013
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K101285
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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

    A CUSTOMER REPORTED THAT THE INTRAOCULAR PRESSURE COMPENSATED FROM A RETINAL SYSTEM WAS NOT FUNCTIONAL DURING A PROCEDURE. THERE HAD BEEN 3 EPISODES OF THIS PROBLEM NOTED FROM THE CUSTOMER. THE PATIENT HAD A SOFT EYE SO THE SURGEON EXCHANGED THE SYSTEM TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313789 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CENTER LXT NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK TOTAL PLUS PACK