BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUOVISC

    MDR report key: 1894936 · Received November 5, 2010

    Report

    Report Number
    3002037047-2010-00175
    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
    Removal / Correction Number
    NA
    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 MANUFACTURING DOCUMENTATION. ADDITIONAL INFO WAS REQUESTED ON 10/12/2010, 10/14/2010, AND 10/18/2010 BY PHONE, FAX AND MAIL. ADDITIONAL 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 PTS' SYMPTOMS WERE RESOLVED SIX DAYS LATER. THIS PT WAS ONE OF TWO THAT WAS SEEN BY A RETINAL SPECIALIST AND IT WAS UNK IF A CULTURE WAS TAKEN. A NURSE CONSULTANT IS SCHEDULED TO VISIT THE FACILITY REGARDING THEIR TASS ISSUES. ADDITIONAL INFO HAS BEEN REQUESTED. THERE ARE FIVE 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 TETRACAINE| OZIL TORSIONAL PHACO HANDPIECE| BSS| I/A HANDPIECE SET