BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUOVISC IBC

    MDR report key: 3862734 · Received May 27, 2014

    Report

    Report Number
    3002037047-2014-00065
    Event Type
    Injury
    Date Received
    May 27, 2014
    Date of Event
    April 2, 2014
    Report Date
    May 5, 2014
    Manufacturer
    ALCON - BELGIUM/ALCON N.V.
    Product Code
    LZP
    PMA / PMN Number
    P840064
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE OR LOT NUMBER INFO HAS RECEIVED BY MANUFACTURING. AS NO COMPLAINT SAMPLE OR LOT NUMBER INFO WAS RECEIVED, NO LOT SPECIFIC INVESTIGATION CAN BE PERFORMED. ALL BATCHES ARE RELEASED ACCORDING TO THE REQUIRED SPECIFICATIONS. ADDITIONAL INFO WAS REQUESTED. (B)(4).

    Description of Event or Problem · 1

    A MANAGER REPORTED A PT PRESENTED WITH TOXIC ANTERIOR SEGMENT SYNDROME (TASS) AFTER A PROCEDURE. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311756 DUOVISC IBC AID, SURGICAL, VISCOELASTIC LZP ALCON - BELGIUM/ALCON N.V. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other