BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 3381368 · Received September 16, 2013

    Report

    Report Number
    2028159-2013-01828
    Event Type
    Malfunction
    Date Received
    September 16, 2013
    Date of Event
    January 1, 2012
    Report Date
    August 19, 2013
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K082845
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RO
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 INFORMATION BECOMES AVAILABLE, IF NO INVESTIGATION CONCLUSION HAS BEEN COMPLETED. LIT REF: ZEMBA M, PAPADATU AC, SIRBU LN, AVRAM C. COMPUTER-ASSISTED PHACOEMULSIFICATION FOR HARD CATARACTS. OFTALMOLOGIA. 2012, 56 (4): 81-4. (B)(4).

    Description of Event or Problem · 1

    IN A LITERATURE REPORT EVALUATING THE EFFICIENCY OF NEW TORSIONAL PHACOEMULSIFICATION SOFTWARE IN HARD NUCLEUS CATARACT EXTRACTION, 5 PATIENTS IN GROUP 1 (PHACOEMULSIFICATION WITH IP SOFTWARE) IN 13 PATIENTS IN GROUP 2 (PHACOEMULSIFICATION WITHOUT IP SOFTWARE) EXPERIENCED OCCLUSION THAT NEEDED MANUAL DESOBSTRUCTION. THE PATIENTS UNDERWENT PHACOEMULSIFICATION PERFORMED BY THE SAME SURGEON, USING THE SAME TECHNIQUE (STOP AND CHOP).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465060 INFINITI VISION SYSTEM OZIL PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER INFINITI OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK