BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUOVISC UNKNOWN

    MDR report key: 2202072 · Received August 5, 2011

    Report

    Report Number
    3002037047-2011-00048
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    July 6, 2011
    Report Date
    July 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 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 INFORMATION WAS REQUESTED BY FAX AND BY MAIL. (B)(4).

    Description of Event or Problem · 1

    AN OPHTHALMIC SURGEON REPORTED A PATIENT WHO PRESENTED WITH POSITIVE ENDOPHTHALMITIS ONE WEEK FOLLOWING CATARACT SURGERY. THE PATIENT WAS HOSPITALIZED AND TREATED WITH ANTIBIOTIC INJECTIONS IN THE RIGHT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THIS IS THE SECOND REPORT OF FOUR MEDICAL DEVICE REPORTS FOR THIS FACILITY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R PHACO TIP| BALANCED SALT SOLUTION| CUSTOM PAK