BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISCOVISC

    MDR report key: 2052574 · Received April 8, 2011

    Report

    Report Number
    3002037047-2011-00015
    Event Type
    Injury
    Date Received
    April 8, 2011
    Date of Event
    February 23, 2011
    Report Date
    March 11, 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
    MH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE COMPLAINT DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RECEIVED FOR EVALUATION. THERE ARE NO SIMILAR REPORTS FOR LOT 10A14D. INVESTIGATION OF BATCH RECORDS COMPOUNDING AND FILING: 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. ADDITIONAL INFORMATION HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    AN OPHTHALMIC SURGEON REPORTED HE DIAGNOSED 3 TO 4 PATIENTS WITH ENDOPHTHALMITIS AFTER USING THIS PRODUCT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISCOVISC AID, SURGICAL, VISCOELASTIC LZP ALCON - BELGIUM/S.A. ALCON-COUVREUR N.V. NA 10A14D

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention