BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYS OZIL

    MDR report key: 3893713 · Received June 4, 2014

    Report

    Report Number
    2028159-2014-01008
    Event Type
    Injury
    Date Received
    June 4, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 9, 2014
    Manufacturer
    ALCON -IRVINE TECH CTR
    Product Code
    HQC
    PMA / PMN Number
    K082845
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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 CUSTOMER REPORTED A PT EXPERIENCED A HIGH INCIDENT OF CORNEAL EDEMA DURING A PROCEDURE. THERE WAS NO PROBLEMS WITH THE SYSTEM THE SURGEON NOTED. THE PROCEDURE WAS COMPLETED. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327349 INFINITI VISION SYS OZIL PHACOFRAGMENTATION SYS HQC ALCON -IRVINE TECH CTR INFINITI OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other