BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUOVISC

    MDR report key: 2516735 · Received March 30, 2012

    Report

    Report Number
    3002037047-2012-00061
    Event Type
    Injury
    Date Received
    March 30, 2012
    Date of Event
    February 13, 2012
    Report Date
    February 29, 2012
    Manufacturer
    ALCON - BELGIUM/S.A. ALCON-COUVREUR N.V.
    Product Code
    LZP
    PMA / PMN Number
    P840064
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MFG DOCUMENTATION. ADDITIONAL INFO WAS REQUESTED BY PHONE, FAX, AND MAIL. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A PT THAT PRESENTED WITH CORNEAL INFLAMMATION ASSOCIATED WITH STROMA INFLAMMATION, CORNEAL ENDOTHELIUM INFLAMMATION AND BULLOUS KERATITIS THREE DAYS FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE PT WAS HOSPITALIZED FOR ONE RIGHT TO OBSERVE FOR POSSIBLE ENDOPHTHALMITIS. ENDOPHTHALMITIS WAS NOT CONFIRMED FOLLOWING COMPLETE EXAMINATION. FIFTEEN DAYS FOLLOWING SURGERY, THE CORNEAL INFLAMMATION REMAINED AND THE PT'S VISION HAD NOT IMPROVED. IN A FOLLOW-UP, THE SURGEON INDICATED THAT THE PT WAS DIAGNOSED WITH TOXIC ANTERIOR SEGMENT SYNDROME (TASS). THE PT WAS TREATED WITH MEDICATIONS AND RECOVERED WITH NO CONSEQUENCES. THE SURGEON NOTED THAT DURING SURGERY THE NATURAL LENS FRAGMENTS WERE DIFFICULT TO CATCH AND SEEMED TO BE TRAPPED IN THE PRODUCT. THE SURGEON ALSO NOTED THAT AT THE TIME OF THE EVENT, THE WEATHER WAS VERY COLD AND HE WONDERED IF THE PRODUCT COULD HAVE BEEN AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUOVISC AID, SURGICAL, VISCOELASTIC LZP ALCON - BELGIUM/S.A. ALCON-COUVREUR N.V. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Hospitalization| R ANTIBIOTIC (CEFUROXIME BY INTRAOCULAR INJECTION