BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUOVISC

    MDR report key: 1894946 · Received November 5, 2010

    Report

    Report Number
    3002037047-2010-00178
    Event Type
    Injury
    Date Received
    November 5, 2010
    Date of Event
    September 29, 2010
    Report Date
    October 8, 2010
    Manufacturer
    ALCON-BELGIUM/S.A. ALCON-COUVREUR N.V.
    Product Code
    LZP
    PMA / PMN Number
    P840064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE, THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MFG DOCUMENTATION. ADD'L INFO WAS REQUESTED ON 10/12/2010, 10/14/2010, AND 10/18/2010 BY PHONE, FAX AND MAIL. ADD'L INFO WAS RECEIVED ON 10/13/2010 AND 10/14/2010 BY PHONE. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED, FIVE CASES OF TASS AT THEIR FACILITY. ALL FIVE SURGERIES WERE PERFORMED ON THE SAME DAY AND ALL PT'S SYMPTOMS WERE RESOLVED 6 DAYS LATER. THIS PT WAS ONE OF THREE THAT WAS NOT SEEN BY A RETINAL SPECIALIST. NO CULTURE WAS TAKEN. A NURSE CONSULTANT IS SCHEDULED TO VISIT THE FACILITY REGARDING THEIR TASS ISSUES. ADD'L INFO REQUESTED. THERE ARE 5 MEDICAL DEVICE REPORTS ASSOCIATED WITH THESE EVENTS. THIS REPORT IS ONE OF FIVE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other BSS| OZIL TORSIONAL PHACO HANDPIECE| TETRACAINE| I/A HANDPIECE SET