BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 2191924 · Received July 22, 2011

    Report

    Report Number
    2028159-2011-00865
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 22, 2011
    Report Date
    June 22, 2011
    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
    IA, US
    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 HOSPITAL PURCHASING REP REPORTED THAT DURING THE SCULPTING PHASE OF PHACOEMULSIFICATION SURGERY, BUBBLES WERE SEEN IN THE EYES OF SIX PTS. ADD'L INFO FROM A NURSE INDICATED THAT IT SEEMED LIKE THE BUBBLES WERE COMING FROM THE PHACO TIP AND THEY OCCLUDED THE VISION OF THE SURGEON. THE SURGEON ASPIRATED THE BUBBLES AND THE SURGERIES WERE COMPLETED WITH NO HARM TO THE PTS. PT IDENTIFIERS WERE PROVIDED FOR ONLY THREE OF THE PTS. THIS REPORT CONCERNS THE THREE PTS FOR WHOM NO IDENTIFIERS WERE PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK