BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISCOVISC

    MDR report key: 2378651 · Received December 7, 2011

    Report

    Report Number
    3002037047-2011-00089
    Event Type
    Injury
    Date Received
    December 7, 2011
    Date of Event
    November 2, 2011
    Report Date
    November 7, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL PRODUCT ASSOCIATED WITH THIS REPORT WAS NOT RECEIVED FOR EVALUATION AND NOT ENOUGH INFORMATION WAS PROVIDED FROM THE ACCOUNT TO PROPERLY COMPLETE AN INVESTIGATION. ADDITIONAL INFORMATION WAS REQUESTED BY PHONE AND MAIL ON 11/07/2011, 11/08/2011, 11/09/2011 AND 11/29/2011. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED TWO CASES OF SUSPECTED TASS (TOXIC ANTERIOR SEGMENT SYNDROME) ONE DAY FOLLOWING CATARACT SURGERY. BOTH CASES PRESENTED WITH HYPOPYON AND POSITIVE CELLS AND FLARE. NO CULTURES WERE TAKEN. THE PATIENTS WERE TREATED WITH MEDICATIONS. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THESE EVENTS. THIS REPORT IS FOR THE SECOND PATIENT.

    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 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention