BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE

    MDR report key: 15807602 · Received November 16, 2022

    Report

    Report Number
    3002037047-2022-00074
    Event Type
    Injury
    Date Received
    November 16, 2022
    Date of Event
    November 1, 2022
    Report Date
    February 22, 2023
    Manufacturer
    ALCON - COUVREUR N.V./ALCON - BELGIUM
    Product Code
    LZP
    PMA / PMN Number
    P840064
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. LITERATURE ARTICLE: OLIVER SCHWENN, H. BURKHARD DICK, FRANK KRUMMENAUER, STEFAN CHRISTMANN, ANNETTE VOGEL, NORBERT PFEIFFER " HEALON5 VERSUS VISCOAT DURING CATARACT SURGERY: INTRAOCULAR PRESSURE, LASER FLARE AND CORNEAL CHANGES " (GRAEFE¿S ARCH CLIN EXP OPHTHALMOL 2000 861-867). THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    NO FURTHER EVALUATION OR ROOT CAUSE ANALYSIS CAN BE CONDUCTED AT THIS TIME. NO ROOT CAUSE COULD BE DETERMINED AS NO SAMPLE OR LOT CODE WAS PROVIDED FOR ANALYSIS. NO ACTION IS WARRANTED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A STUDY WAS REPORTED THAT AN OPHTHALMIC VISCO SURGICAL DEVICE WAS USED IN A PROCEDURE AND PATIENTS EXPERIENCED HIGH INTRA OCULAR PRESSURE (IOP) AND MEDICATION WAS PROVIDED. THE PRODUCT ALSO HAD REMNANTS IN THE EYE. NO FURTHER INFORMATION EXPECTED DUE TO THE UNLIKELIHOOD OF OBTAINING THE INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1416073 VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE AID, SURGICAL, VISCOELASTIC LZP ALCON - COUVREUR N.V./ALCON - BELGIUM NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other| R