BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUOVISC UNKNOWN

    MDR report key: 2391794 · Received December 20, 2011

    Report

    Report Number
    3002037047-2011-00112
    Event Type
    Injury
    Date Received
    December 20, 2011
    Date of Event
    November 10, 2011
    Report Date
    November 21, 2011
    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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PRODUCT RETURNED. BATCH RECORD REVIEW SHOWED THAT ALL TESTING RESULTS ARE WITHIN SPECIFICATION. INVESTIGATION OF BATCH RECORDS COMPOUNDING AND FILLING FOR THE POSSIBLY INVOLVED LOTS: NO REMARKS RELATED TO THE MANUFACTURING PROCESS, THE STERILIZATION OF RAW MATERIALS, EQUIPMENT, COMPONENTS AND PRODUCT STERILIZATION. ALL RESULTS OF CHEMICAL, MICROBIOLOGICAL AND TOXICOLOGY TESTS WERE WITHIN SPECIFICATION. NO OTHER ADVERSE EVENTS HAVE BEEN RECEIVED SO FAR FOR BOTH POSSIBLY INVOLVED LOTS. ADDITIONAL INFO WAS REQUESTED BY PHONE AND MAIL ON 11/21/2011, 11/22/2011, 11/29/2011 AND 12/15/2011. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A FACILITY REPORTED FOUR CASES OF TOXIC ANTERIOR SEGMENT SYNDROME (TASS) FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. ADDITIONAL INFO HAS BEEN REQUESTED. THERE ARE FOUR MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE SECOND PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other INTRAOCULAR LENS