BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUOVISC IBC

    MDR report key: 2463574 · Received February 16, 2012

    Report

    Report Number
    1119421-2012-00170
    Event Type
    Injury
    Date Received
    February 16, 2012
    Date of Event
    December 1, 2011
    Report Date
    January 17, 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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY; THE PRODUCT HAS NOT BEEN RECEIVED FOR EVAL. PRODUCT HISTORY RECORDS COULD NOT BE RECEIVED BECAUSE THE REPORTER DID NOT PROVIDE A LENS SERIAL NUMBER, LOT NUMBER, OR ANY IDENTIFICATION TRACEABLE TO THE MFG DOCUMENTATION. ADDITIONAL INFO HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    AN OPERATING ROOM NURSE REPORTED A FEW CASES OF TASS. THEY ARE NOT SURE IF THESE CASES ARE RELATED TO THIS PRODUCT. THERE ARE CURRENTLY NO PT IDENTIFIERS. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other