BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAUREATE WORLD PHACO SYSTEM

    MDR report key: 1791582 · Received August 6, 2010

    Report

    Report Number
    2028159-2010-01394
    Event Type
    Malfunction
    Date Received
    August 6, 2010
    Date of Event
    July 3, 2010
    Report Date
    July 8, 2010
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K021566
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HANDPIECE IS RETURNING FOR IN-HOUSE EVALUATION. 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

    ADVERSE EVENT(S): ¿NO PT INJURY REPORTED¿ (NO CONSEQUENCES OR IMPACT TO PT). PRODUCT PROBLEM(S): ¿VITRECTOMY HANDPIECE AND TIP WERE NOT WORKING¿ (DEVICE ISSUE). THE SURGEON REPORTED THE VITRECTOMY HANDPIECE AND TIP WERE NOT WORKING DURING SURGERY. ADD¿L INFO ON THE EVENT HAS BEEN REQUESTED. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAUREATE WORLD PHACO SYSTEM PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER LAUREATE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI