BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROVISC

    MDR report key: 2489084 · Received March 9, 2012

    Report

    Report Number
    3002037047-2012-00058
    Event Type
    Injury
    Date Received
    March 9, 2012
    Date of Event
    February 7, 2012
    Report Date
    February 8, 2012
    Manufacturer
    ALCON - BELGIUM/ S.A. ALCON-COUVREUR N.V.
    Product Code
    LZP
    PMA / PMN Number
    P890047
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR EVALUATION. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. ADDITIONAL INFORMATION WAS REQUESTED ON 02/09/2012, 02/16/2012, AND 02/27/2012 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 02/20/2012. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THREE PATIENTS WITH TOXIC ANTERIOR SEGMENT SYNDROME (TASS) FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. IN A FOLLOW UP, THE NURSE REPORTED THE PATIENT PRESENTED WITH DENSE FIBRIN CONSOLIDATION AND TWO PLUS CELLS IN THE ANTERIOR CHAMBER AND CORNEAL EDEMA ON THE FIRST POSTOPERATIVE DAY. THE PATIENT WAS TREATED WITH MEDICATIONS. THE SURGEON REPORTED EVENT RESOLVED WITH TREATMENT. THERE ARE FIFTEEN MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE THIRD PATIENT, STAND ALONE VISCOELASTIC.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention BALANCE SALT SOLUTION PLUS| CUSTOM PAK| ALCAINE - PREOPERATIVE MEDICATIONS| INFINITI OZIL| PHENYLEPHRINE| TROPICAMIDE| ZYMAXID| MONARCH D CARTRIDGE AND HANDPIECE| 27GA REUSABLE CANNULAS| ERYTHROMYCIN OINTMENT| CAVI-CLEAN| 5% BETADINE| CASSETTE| KNIFE| DUOVISC| SN6AT5| CYLOGEL