BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUOVISC

    MDR report key: 3900049 · Received May 27, 2014

    Report

    Report Number
    3002037047-2014-00066
    Event Type
    Injury
    Date Received
    May 27, 2014
    Date of Event
    April 29, 2014
    Report Date
    April 29, 2014
    Manufacturer
    ALCON - BELGIUM / ALCON N.V.
    Product Code
    LZP
    PMA / PMN Number
    P840064
    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 DURING A CATARACT SURGERY. IT HAPPENED AFTER MAKING THE RHEXI 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 IRRIGATING 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 THOUGHT AT FIRST THAT IT WAS CAUSED BY A CLOG DUE TO THE VISCOELASTIC. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED TO DATE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS FOR THE VISCOELASTIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311978 DUOVISC AID, SURGICAL, VISCOELASTIC LZP ALCON - BELGIUM / ALCON N.V. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CENTURION VISION SYSTEM