BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CENTURION VISION SYS

    MDR report key: 3900043 · Received May 27, 2014

    Report

    Report Number
    2028159-2014-00986
    Event Type
    Injury
    Date Received
    May 27, 2014
    Date of Event
    April 29, 2014
    Report Date
    April 29, 2014
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQC
    PMA / PMN Number
    K121555
    Adverse Event
    Yes
    Product Problem
    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 INFO HAS BEEN REQUESTED BUT NOT RECEIVED TO DATE. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT A CORNEAL BURN OCCURED AFTER MOVING THE CORTEX, UPON THE FIRST SCULPTING DURING CATARACT PROCEDURE. AS A RESULT OF THE EVENT, THE PT EXPERIENCED WOUND LEAK, WHICH REQUIRED THREE SUTURES TO CLOSE THE WOUND AND PLACEMENT OF A RIGID GAS PERMEABLE CONTACT LENS. THE PT ALSO EXPERIENCED POST-OP IRREGULAR ASTIGMATISM. AS INDICATED IN THE QUESTIONNAIRE, THE SURGEON BELIEVED THAT POSSIBLE CONTRIBUTING FACTORS FOR THE REPORTED EVENT WERE THE OCCLUSION OF THE PHACO HANDPIECE, THE SYSTEM, AND NO MORE OZIL AT THE MOMENT OF THE EVENT. THE SURGEON ALSO NOTED THAT THE OCCLUSION BELL WAS EMITTED DURING SURGERY. THE HANDPIECE REQUIRED TO BE REMOVED TWICE FROM THE EYE AND EXCHANGED TWICE, THE PHACO-TIP WAS CHANGED TWICE, AND THE CASSETTE WAS REPRIMED ALSO TWICE DURING CATARACT PROCEDURE. ADDITIONAL INFO HAS BEEN REQUESTED BUT NOT RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312066 CENTURION VISION SYS PHACOFRAGMENTATION SYS HQC ALCON RESEARCH, LTD. / HUNTINGTON NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention CENTURION OZIL HANDPIECE| OZIL TORSIONAL PHACO HANDPIECE| DUOVISC| CASSETTE