BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROVISC

    MDR report key: 2489080 · Received March 9, 2012

    Report

    Report Number
    3002037047-2012-00055
    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

    EVAL SUMMARY: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR EVAL. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MFG DOCUMENTATION. ADD'L INFO WAS REQUESTED ON 02/09/2012, 02/16/2012, AND 02/27/2012. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THREE PTS WITH TOXIC ANTERIOR SEGMENT SYNDROME (TASS) FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. IN A FOLLOW UP, THE NURSE REPORTED THE PT PRESENTED WITH FIBRIN, CORNEAL EDEMA, IRITIS, AND INTRAOCULAR PRESSURE ELEVATION (IOP) ON THE FIRST DAY POSTOPERATIVELY. THE PT WAS TREATED WITH MEDICATIONS. FOR THIS PT, AN ANTERIOR CHAMBER WASHOUT AND CORTEX REMOVAL WAS PERFORMED AT ONE WEEK POSTOPERATIVE. THE SURGEON REPORTED THE PT'S SYMPTOMS WERE RESOLVING. THERE ARE FIFTEEN MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE SECOND PT, 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 80 YR Required Intervention BALANCE SALT SOLUTION PLUS: SN(B)(4)| MONARCH D CARTRIDGE| INFINITY OZIL| HANDPIECE| DUOVISC| KNIFE| 5% BETADINE| 27 GA REUSABLE CANNULAS| CUSTOM PAK| ZYMAXID USED PREOPERATIVELY| CAVI-CLEAN| CASSETTE