BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYS

    MDR report key: 3881425 · Received April 9, 2014

    Report

    Report Number
    2028159-2014-00590
    Event Type
    Malfunction
    Date Received
    April 9, 2014
    Date of Event
    March 11, 2014
    Report Date
    March 12, 2014
    Manufacturer
    ALCON -IRVINE TECH CTR
    Product Code
    HQC
    PMA / PMN Number
    K101285
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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 THERE WAS AN UNUSUAL NOISE FROM THE SYSTEM DURING A CATARACT/VITRECTOMY SURGICAL PROCEDURE. THE SYSTEM WAS SWITCHED OUT TO COMPLETE THE SURGERY. THERE WAS NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213368 CONSTELLATION VISION SYS UNIT, PHACOFRAGMENTATION HQC ALCON -IRVINE TECH CTR L NA

    Patients

    Seq Age Sex Outcome Treatment
    1