BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 2072399 · Received April 8, 2011

    Report

    Report Number
    2028159-2011-00351
    Event Type
    Malfunction
    Date Received
    April 8, 2011
    Date of Event
    March 11, 2011
    Report Date
    March 11, 2011
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K082845
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY WHEN ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT A RESTART MESSAGE DISPLAYED BEFORE AND DURING A PROCEDURE. ADD'L INFO WAS REC'D REPORTING IT WAS NECESSARY OF THE SURGEON TO MANUALLY EXTRACT THE REMAINING CRYSTALLINE FRAGMENTS FROM THE PT'S EYE WITH A SYRINGE. THE SURGERY WAS COMPLETED WITHOUT FURTHER INCIDENT FOLLOWING A 15 MINUTE DELAY. THERE WAS NO HARM OR INJURY TO THE PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1