BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 3770957 · Received December 19, 2013

    Report

    Report Number
    3008772169-2013-00110
    Event Type
    Injury
    Date Received
    December 19, 2013
    Date of Event
    November 1, 2013
    Report Date
    December 6, 2013
    Manufacturer
    ALCON- LENSX LASERS, INC.
    Product Code
    OOE
    PMA / PMN Number
    K082845
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 ADDITIONAL REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A SURGEON INFORMED A COMPANY REPRESENTATIVE OF CASE OF ENDOPHTHALMITIS OBSERVED 4 DAYS POST LASER ASSISTED CATARACT SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667728 INFINITI VISION SYSTEM OZIL PHACOFRAGMENTATION SYSTEM OOE ALCON- LENSX LASERS, INC. INFINITI OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other LENSX LASER