BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYS

    MDR report key: 4173169 · Received October 10, 2014

    Report

    Report Number
    2028159-2014-01864
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    September 13, 2014
    Report Date
    September 14, 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
    BR
    Reporter Occupation
    UNKNOWN

    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 CUSTOMER REPORTED THAT THE FOOTSWITCH OF THE SYS DID NOT RESPOND PRIOR TO PROCEDURES. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643034 CONSTELLATION VISION SYS UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CTR L NA

    Patients

    Seq Age Sex Outcome Treatment
    1