BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUOVISC OPHTHALMIC VISCOSURGICAL DEVICE

    MDR report key: 14671068 · Received June 11, 2022

    Report

    Report Number
    2184002-2022-00002
    Event Type
    Injury
    Date Received
    June 11, 2022
    Date of Event
    April 8, 2022
    Report Date
    July 26, 2022
    Manufacturer
    LIFECORE BIOMEDICAL, LLC
    Product Code
    LZP
    PMA / PMN Number
    P840064
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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 WILL CONTINUE TO MONITOR DATA FOR EVIDENCE OF ADVERSE TRENDING AND TAKE FURTHER ACTION, AS APPROPRIATE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION RECEIVED FOLLOWING SUBMISSION OF THE INITIAL REPORT, SUSPECT PRODUCT IS OPHTHALMIC HANDPIECE AND NOT THE OPHTHALMIC VISCOSURGICAL DEVICE FOR THE REPORTED EVENT. THE UPDATED REPORT FOR THE SUSPECTED HANDPIECE HAS BEEN SUBMITTED UNDER MFG REPORT NUM. 2028159-2022-00900. NO FURTHER REPORTS WILL BE SCHEDULED UNDER MFG REPORT NUM. 2184002-2022-00002 THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A PHYSICIAN REPORTED THAT A PATIENT EXPERIENCED TOXIC ANTERIOR SEGMENT SYNDROME, SLIGHT PAIN, TYNDALL, CONJUNCTIVAL INFLAMMATION, AQUEOUS CELLS, CONJUNCTIVAL INFECTION WHEN AN OPHTHALMIC VISCOELASTIC WAS USED. PATIENT WAS GIVEN WITH STEROIDS, ANTIBIOTICS AND NON-STEROIDAL ANTI-INFLAMMATORY MEDICATIONS. SYMPTOMS WERE RESOLVED. NO FURTHER INFORMATION EXPECTED AS CUSTOMER WAS UNWILLING TO PROVIDE.

    Description of Event or Problem · 0

    ADDITIONAL CORRECTED INFORMATION RECEIVED INDICATING THAT THE SUSPECT PRODUCT IS OPHTHALMIC HANDPIECE AND NOT OPHTHALMIC VISCOSURGICAL DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2821969 DUOVISC OPHTHALMIC VISCOSURGICAL DEVICE AID, SURGICAL, VISCOELASTIC LZP LIFECORE BIOMEDICAL, LLC NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention| O ACUNEX VARIO, AN6V 20 D.