BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTALLATION VISION SYS

    MDR report key: 4152491 · Received October 6, 2014

    Report

    Report Number
    2028159-2014-01799
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Date of Event
    September 5, 2014
    Report Date
    September 8, 2014
    Manufacturer
    ALCON -IRVINE TECH CTR
    Product Code
    HQC
    PMA / PMN Number
    K101285
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PROBE WAS RETURNED FOR EVALUATION FOR NOT CUTTING. THE DEVICE HISTORY RECORDS (DHR) FOR FOUR PROBE LOTS MANUFACTURED IN MARCH AND APRIL 2014 WERE REVIEWED. THERE WERE UNRELATED REINSPECTIONS FOR ADHESIVE ON NEEDLES FOUND, HOWEVER, ALL SUSPECT PRODUCT WERE RE-INSPECTED AND THE PRODUCT WAS RELEASED ACCORDING TO THE MFR'S ACCEPTANCE CRITERIA. BECAUSE A SAMPLE WAS NOT RETURNED AND THE LOTS REVIEWED HAD NO RELATED ABNORMALITIES TO THE COMPLAINT ISSUE, THE ROOT CAUSE FOR THE CUSTOMER COMPLAINT ISSUE CANNOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    THE CUTTER WAS WORKING DURING CALIBRATION PRIOR TO SURGERY, HOWEVER WHEN THE SURGEON WAS STARTING THE SURGERY, IT DID NOT WORK (IT COULD NOT CUT THE VITREOUS). IMMEDIATELY IT WAS REPLACED AND THE NEW CUTTER WORKED WELL. THERE WAS NO PT HARM REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622225 CONSTALLATION VISION SYS UNIT, PHACOFRAGMENTATION HQC ALCON -IRVINE TECH CTR NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR COMBINED PROCEDURE PAK, 23 GUAGE,| 5000 CUTS PER MIN, 1.1