BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE

    MDR report key: 15813387 · Received November 17, 2022

    Report

    Report Number
    3002037047-2022-00076
    Event Type
    Injury
    Date Received
    November 17, 2022
    Date of Event
    November 1, 2022
    Report Date
    February 17, 2023
    Manufacturer
    ALCON - COUVREUR N.V./ALCON - BELGIUM
    Product Code
    LZP
    PMA / PMN Number
    P840064
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN
    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: GEORG RAINER, RUPERT MENAPACE, OLIVER FINDL, BARBARA KISS, VANESSA PETTERNEL, MICHAEL GEORGOPOULOS, BARBARA SCHNEIDER" INTRAOCULAR PRESSURE RISE AFTER SMALL INCISION CATARACT SURGERY: A RANDOMISED INTRAINDIVIDUAL COMPARISON OF TWO DISPERSIVE VISCOELASTIC AGENTS" (BJOPHTHALMOL AUG/2001:85 139-142). THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    NO LOT CODE OR SAMPLE PROVIDED. 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 REPORTED THAT POST OPERATIVELY TO A CATARACT PROCEDURE AN OPHTHALMIC VISCO SURGICAL DEVICE WAS INVOLVED IN A CATARACT PROCEDURE AND PATIENTS EXPERIENCED ELEVATED INTRA OCULAR PRESSURE (IOP), PROVIDED WITH MEDICATION. NO FURTHER INFORMATION EXPECTED DUE TO THE UNLIKELIHOOD OF OBTAINING THE INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211812 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