BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION

    MDR report key: 1872160 · Received October 14, 2010

    Report

    Report Number
    2028159-2010-01965
    Event Type
    Malfunction
    Date Received
    October 14, 2010
    Date of Event
    August 8, 2010
    Report Date
    September 14, 2010
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K063583
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED: PHAKO-PACK IS LEAKY. WATER WAS LEAKING OUT OF IT INTO THE DEVICE. NO PATIENT IMPACT WAS REPORTED. ADD'L INFO WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSTELLATION UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CENTER CONSTELLATION 1014116H

    Patients

    Seq Age Sex Outcome Treatment
    1 CONSTELLATION SURGICAL PAK