BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE

    MDR report key: 15804496 · Received November 16, 2022

    Report

    Report Number
    3002037047-2022-00067
    Event Type
    Injury
    Date Received
    November 16, 2022
    Date of Event
    November 1, 2022
    Report Date
    March 1, 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
    GM
    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: "EFFECT OF HEALON5 AND 4 OTHER VISCOELASTIC SUBSTANCES ON INTRAOCULAR PRESSURE AND ENDOTHELIUM AFTER CATARACT SURGERY" (J CATARACT REFRACT SURG FEB/2001:27 214-218). THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    ALL BATCHES ARE RELEASED ACCORDING TO THE REQUIRED SPECIFICATIONS. A LOT CODE WOULD BE REQUIRED FOR REVIEW OF THE COMPLAINT HISTORY AND THE BATCH DOCUMENTATION. ADVERSE EVENTS ARE FOLLOWED-UP BY MANUFACTURER. NO PRODUCT RETURNED FOR EVALUATION. AS NO PRODUCT RETURNED AND ALL INITIAL TESTING RESULTS ARE WITHIN SPECIFICATION A CONCLUSIVE ROOT CAUSE COULD NOT BE DETERMINED. ALL BATCHES ARE RELEASED ACCORDING TO THE REQUIRED SPECIFICATIONS. AS NO PRODUCT IS RETURNED, THE COMPLAINT COULD NOT BE VERIFIED AND THEREFORE NO ACTION IS INITIATED. HOWEVER FURTHER TRENDING IS PERFORMED THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A STUDY REPORTED THAT AN OPHTHALMIC VISCO SURGICAL DEVICE WAS USED IN A STUDY AND THE VOLUNTEERS EXPERIENCED HIGH INTRA OCULAR PRESSURE (IOP) AND ENDOTHELIAL CELL LOSS. NO FURTHER INFORMATION EXPECTED AS CUSTOMER WAS UNWILLING TO PROVIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355629 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