BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUOVISC UNKNOWN

    MDR report key: 2452456 · Received February 10, 2012

    Report

    Report Number
    3002037047-2012-00031
    Event Type
    Injury
    Date Received
    February 10, 2012
    Date of Event
    January 4, 2012
    Report Date
    January 11, 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 Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO SAMPLE PRODUCT RETURNED FOR ANALYSIS. THE BATCH 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 ON 01/12/2012, 01/13/2012, 01/20/2012 AND 01/27/2012 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 02/08/2012. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED FOUR PATIENTS EXHIBITING TOXIC ANTERIOR SEGMENT SYNDROME, (TASS) FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE SYMPTOMS INCLUDED MORE EXCESSIVE THAN NORMAL INFLAMMATION, FIBRIN COATED IOLS THAT TRACK BACK TO THE WOUND. THERE WAS ONE SURGEON INVOLVED AND THE SURGERIES OCCURRED ON THREE SEPARATE DAYS. ADDITIONAL INFORMATION WAS RECEIVED. THE PATIENT RECEIVED A STEROID/ANTIBIOTIC SUBCONJUNCTIVAL INJECTION DURING THE SURGERY. THERE WAS NO UNPLANNED SURGICAL INTERVENTION. THE PATIENT'S SYMPTOMS RESOLVED WITH TREATMENT. THERE ARE FOUR MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE THIRD PATIENT.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention LIDOCAINE| INTRAOCULAR LENS| IOPIDINE DROPS| CARBACHOL| INFINITI| TIMOPTIC| ANCEF| DEXAMETHASONE| I/A STRAIGHT SILICONE TIP| BSS WITH EPINEPHRINE| MONARCH C CARTRIDGE| OZIL HANDPIECE