BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 4101689 · Received September 15, 2014

    Report

    Report Number
    2028159-2014-01698
    Event Type
    Injury
    Date Received
    September 15, 2014
    Date of Event
    August 7, 2014
    Report Date
    August 18, 2014
    Manufacturer
    ALCON ¿ IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K021566
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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 INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED A PATIENT EXPERIENCED ENDOPHTHALMITIS, IN THE LEFT EYE AFTER CATARACT SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570232 INFINITI VISION SYSTEM PHACOFRAGMENTATION SYSTEM HQC ALCON ¿ IRVINE TECHNOLOGY CENTER INFINITI NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other MONARCH C CARTRIDGE| BALANCED SALT SOLUTION| EPINEPHRINE| OZIL TORSIONAL PHACO HANDPIECE| DUOVISC