BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CENTURION VISION SYSTEM

    MDR report key: 3900053 · Received May 27, 2014

    Report

    Report Number
    2028159-2014-00981
    Event Type
    Injury
    Date Received
    May 27, 2014
    Date of Event
    April 29, 2014
    Report Date
    April 29, 2014
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K121555
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    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. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED TO DATE. (B)(4).

    Description of Event or Problem · 1

    AN OPTHALMIC SURGEON REPORTED THAT A PATIENT EXPERIENCED A CORNEAL BURN AT THE INCISION SITE DURING A CATARACT SURGERY. IT HAPPENED AFTER MAKING THE RHEXIS AND REMOVING THE CORTEX. DURING SCULPTING, THE SYSTEM DEMONSTRATED OCCLUSION AND THERE WAS A CORNEAL BURN INSTANTLY. THE SURGEON REMOVED THE HANDPIECE OUT OF THE EYE AND TESTED IT AGAIN IN A PIT FILLED WITH INTRAOCULAR IRRIGATION SOLUTION AND NO OCCLUSION WAS DEMONSTRATED ANYMORE. AFTER CONTINUING THE PROCEDURE, THIS SCENARIO HAPPENED AGAIN. THE SAME STEPS WERE REPEATED, BUT THE DAMAGE HAD ALREADY BEEN THERE FROM THE FIRST SECOND. AFTER THIS REPETITION, THE OCCLUSION WAS GONE AND THE SURGEON WAS ABLE TO CONTINUE THE PROCEDURE WITHOUT ANY FURTHER ISSUES. SUTURES WERE REQUIRED AND SURGERY WAS DELAYED FOR 5 MINUTES. THE SURGEON THOUGH AT FIRST THAT IT WAS CAUSED BY A CLOG DUE TO THE VISCOELASTIC. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED TO DATE. THIS IS THE SEVENTH OF THIRTEEN MEDICAL DEVICE REPORTS BEING FILED FOR THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312068 CENTURION VISION SYSTEM PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention DUOVISC