BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISCOAT

    MDR report key: 2231170 · Received August 26, 2011

    Report

    Report Number
    3002037047-2011-00060
    Event Type
    Injury
    Date Received
    August 26, 2011
    Date of Event
    July 26, 2011
    Report Date
    July 28, 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
    NJ, US
    Reporter Occupation
    OTHER

    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 07/29/2011, 08/01/2011, 08/02/2011, 08/04/2011 AND 08/23/2011 BY FAX, PHONE AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BE RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT A PT WAS DIAGNOSED WITH TOXIC ANTERIOR SEGMENT SYNDROME (TASS) ON THE FIRST POST OPERATIVE DAY FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE SURGEON STATED THERE WAS NO SIGN OF INFECTION AND THE PT WAS REPORTED TO BE IMPROVING WITH THE USE OF STEROIDS. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THIS REPORT IS FOR THE FIRST MEDICAL DEVICE ASSOCIATED WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention ACRYSOF RESOTR IOL| PROVISC AND CUSTOM PAK - DATE UNK