BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 1760860 · Received July 14, 2010

    Report

    Report Number
    2028159-2010-01175
    Event Type
    Malfunction
    Date Received
    July 14, 2010
    Date of Event
    June 10, 2010
    Report Date
    June 14, 2010
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CTR
    Product Code
    HQC
    PMA / PMN Number
    K021566
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE HAS BEEN RECEIVED AND IN-HOUSE EVAL IS IN PROGRESS. 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 INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "NO PT INJURY" (NO CONSEQUENCES OR IMPACT TO PT). PRODUCT PROBLEM(S): "TIP WAS OCCLUDED" (OCCLUSION WITHIN DEVICE). A CUSTOMER REPORTED DURING SURGERY, IT WAS NOTICED THE TIP WAS OCCLUDED. THE TIP WAS FLUSHED BUT STILL WOULD NOT WORK. ANOTHER TIP WAS OPENED AND FUNCTIONED AS INTENDED. THERE WAS NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFINITI VISION SYSTEM PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CTR INFINITI 807409M

    Patients

    Seq Age Sex Outcome Treatment
    1