BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYS OZIL

    MDR report key: 3915506 · Received February 26, 2014

    Report

    Report Number
    2028159-2014-00309
    Event Type
    Malfunction
    Date Received
    February 26, 2014
    Date of Event
    January 1, 2014
    Report Date
    January 29, 2014
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CTR
    Product Code
    HQC
    PMA / PMN Number
    K082845
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    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 ADDITIONAL REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED OCCLUSION PROBLEMS DURING MULTIPLE PROCEDURES. THE CASES WERE COMPLETED BY CHANGING THE SETTINGS. THERE WERE NO HARM TO THE PTS REPORTED. THE CUSTOMER INDICATED THE CAUSE WAS DUE TO DENSE CATARACTS OCCLUDING THE HANDPIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118654 INFINITI VISION SYS OZIL PHACOFRAGMENTATION SYS HQC ALCON - IRVINE TECHNOLOGY CTR INFINITI OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK OZIL TORSIONAL HANDPIECE