BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISCOAT

    MDR report key: 2020365 · Received March 11, 2011

    Report

    Report Number
    3002037047-2011-00005
    Event Type
    Injury
    Date Received
    March 11, 2011
    Date of Event
    September 1, 2008
    Report Date
    February 9, 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
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MFG DOCUMENTATION. LITERATURE CITATION: YUAN-CHIEH LEE: THERMAL BURNS CAUSED BY OPHTHALMIC VISCOSURGICAL DEVICE OCCLUSION IN TORSIONAL PHACOEMULSIFICATION: TZU CHI MEDICAL JOURNAL. DECEMBER 2010, VOLUME 22, NUMBER 4. (B)(4) (DEVICE OPERATIONAL ISSUE). (B)(4).

    Description of Event or Problem · 1

    LITERATURE ARTICLE REPORTS THREE CASES OF PHACO BURNS DURING TORSIONAL PHACOEMULSIFICATIONS, WHICH WERE, IN THE RPTR'S OPINION, CAUSED BY THE OPHTHALMIC VISCOSURGICAL DEVICE OCCLUSION. IN ALL THREE CASES, THE PHACO BURNS OCCURRED AT THE BEGINNING OF SCULPTING. THE CORNEAL WOUNDS WERE SUTURED, INTENTIONALLY LEAVING THE ADHESIONS OF THE IRIS TO THE CORNEAL WOUNDS. SEPARATION OF THE CORNEA AND IRIS WERE DONE LATER, AND A CENTRAL ROUND PUPIL WAS ACHIEVED IN CASES TWO AND THREE. ASTIGMATISM IMPROVED WITH TIME IN ALL THREE CASES. THIS IS THE SECOND OF THREE MEDICAL DEVICE REPORTS BEING FILED FOR THIS LITERATURE REPORT AND REPRESENTS CASE 2.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention INFINITI TORSIONAL PHACO HANDPIECE| INFINITI VISION SYSTEM OZIL| INFINITI VISION SYSTEM PAK