BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISCOAT

    MDR report key: 899231 · Received August 17, 2007

    Report

    Report Number
    3002037047-2007-00046
    Event Type
    Injury
    Date Received
    August 17, 2007
    Date of Event
    January 1, 2004
    Report Date
    July 20, 2007
    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
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE ASSOCIATED WITH THIS REPORT HAS NOT BEEN RECEIVED FOR EVALUATION. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER HAS NOT PROVIDED A LOT NUMBER, OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. (B)(4). THE INFORMATION WAS SUPPLIED BY THE MANUFACTURER, NOT THE USER FACILITY. (B)(4). ADDITIONAL INFORMATION WAS REQUESTED ON 07/24/2007 BY MAIL. LITERATURE CITATION: HICKMAN MS, WERNER L, MAMALIS N, SUNG E, GOLDSTEIN D, VROMAN DT, PANDEY SK. INTRAOPERATIVE EXPLANTATION OF TWO SINGLE-PIECE HYDROPHOBIC ACRYLIC INTRAOCULAR LENSES DUE TO SURFACE DEPOSITS. EYE. 2006; VOL. 20: 1054-1060.

    Description of Event or Problem · 1

    LITERATURE REPORT STATES A PHYSICIAN PERFORMED A CATARACT EXTRACTION USING PHACOEMULSIFICATION OF A 2+ NUCLEAR SCLEROTIC CATARACT WITH ANTERIOR CORTICAL CHANGES. THE CAPSULORHEXIS WAS PERFORMED UNDER VISCOELASTIC AND A VISCOELASTIC WAS ALSO INJECTED INTO THE EYE. THE IOL WAS LOADED INTO THE INJECTOR ALONG WITH VISCOELASTIC PRODUCT. THE SURGEON NOTED IT WAS DIFFICULT TO INJECT THE IOL INTO THE EYE. A 'CRUNCHING SOUND' WAS NOTICED UPON INSERTION AND A WHITE, GRANULAR MATERIAL WAS SEEN ON THE LENS AND IN THE ANTERIOR CHAMBER OF THE EYE. THE IOL WAS REMOVED AND A DIFFERENT IOL OF THE SAME LENS MODEL WAS IMPLANTED DURING THE SAME PROCEDURE. ONE WEEK FOLLOWING SURGERY, THE PATIENT DEVELOPED CORNEAL EDEMA WITH A BEST CORRECTED VISUAL ACUITY (BCVA) OF 20/200. THE PATIENT WAS LAST SEEN AT ONE MONTH POSTOPERATIVE, AT THAT TIME, THE EYE WAS QUIET, THE CORNEAL EDEMA HAD RESOLVED, AND THE BCVA WAS 20/30. MDR # 3002037047-2007-00046 (VISCOELASTIC). MDR # 1119421-2007-00345 (IOL).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention MURO 128 OINTMENT| CEFAZOLIN| CLINDAMYCIN| MONARCH II| IOL| PROVISC| BSS| LEVOFLOXACIN