BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYS OZIL

    MDR report key: 3881430 · Received April 9, 2014

    Report

    Report Number
    2028159-2014-00618
    Event Type
    Malfunction
    Date Received
    April 9, 2014
    Date of Event
    March 14, 2014
    Report Date
    March 14, 2014
    Manufacturer
    ALCON -IRVINE TECH CTR
    Product Code
    HQC
    PMA / PMN Number
    K082845
    Removal / Correction Number
    NA
    Product Problem
    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 THAT DURING A CATARACT PROCEDURE, THE SYSTEM DISPLAYED A MESSAGE AND LOCKED. THE CSE WAS COMPLETED WITH AN ALTERNATE SYSTEM. THER WAS NO HARM TO PT. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213958 INFINITI VISION SYS OZIL PHACOFRAGMENTATION SYS HQC ALCON -IRVINE TECH CTR INFINITI OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK