BEUDAMED
    FDA Adverse Event Other Summary report: N

    CONSTELLATION WITH LASER

    MDR report key: 2195141 · Received July 15, 2011

    Report

    Report Number
    2028159-2011-00831
    Event Type
    Other
    Date Received
    July 15, 2011
    Date of Event
    June 17, 2011
    Report Date
    June 17, 2011
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CTR
    Product Code
    HQC
    PMA / PMN Number
    K063583
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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

    A CUSTOMER REPORTED THE 23 GAUGE CUTTER DETACHED UNDER PRESSURE DURING A SURGICAL PROCEDURE. THE BLACK LINE IN THE CUTTER SEPARATED AT THE JOINT WHERE THE TWO PIECES MEET WHEN PLACED UNDER PRESSURE. THE SURGEON DECIDED TO USE A DIFFERENT TECHNIQUE TO COMPLETE THE PROCEDURE. PT IMPACT IS UNK. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSTELLATION WITH LASER UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CTR CONSTELLATION NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other