BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUOVISC OPHTHALMIC VISCOSURGICAL DEVICE

    MDR report key: 14673341 · Received June 13, 2022

    Report

    Report Number
    2184002-2022-00004
    Event Type
    Injury
    Date Received
    June 13, 2022
    Date of Event
    May 10, 2022
    Report Date
    July 27, 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 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. 2028159-2022-00917. NO FURTHER REPORTS WILL BE SCHEDULED UNDER MFG REPORT NUM. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A PHYSICIAN REPORTED THAT AFTER CATARACT SURGERY ON THE LEFT EYE, THE PATIENT FELT PAIN, VISION REDUCED (VISION LOSS) AND THERE WAS A REACTION IN THE ANTERIOR CHAMBER CELL, AND TYNDALL. THERE WAS A MILD CONJUNCTIVAL INFLAMMATION AND DIAGNOSED WITH TOXIC ANTERIOR SEGMENT SYNDROME. THE PATIENT WAS EXAMINED AND RESULT SHOWS AQUEOUS CELL 2+ AND INCREASE IN MACULAR EDEMA AND THE PATIENT RECEIVED AN INTRAVITREAL INJECTION WITH TRIESCENCE. THE PATIENT WAS PRESCRIBED WITH POST OPERATIVE STEROIDS, ANTIBIOTICS AND NON-STEROIDAL ANTI-INFLAMMATORY DRUGS.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1426654 DUOVISC OPHTHALMIC VISCOSURGICAL DEVICE AID, SURGICAL, VISCOELASTIC LZP LIFECORE BIOMEDICAL, LLC NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Other| R ACUNEX VARIO.| DICLOABAK 3X/DAY.| POVIDONE IODINE 10%.| TETRACAÏNE UD.| TOBRADEX 1X/DAY, 5X/DAY (POST-OP).| TOBRAMYCINE.