BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUOVISC OPHTHALMIC VISCOSURGICAL DEVICE

    MDR report key: 11760196 · Received May 3, 2021

    Report

    Report Number
    2184002-2021-00009
    Event Type
    Injury
    Date Received
    May 3, 2021
    Date of Event
    March 20, 2021
    Report Date
    July 2, 2021
    Manufacturer
    LIFECORE BIOMEDICAL, LLC
    Product Code
    LZP
    UDI-DI
    00380651831353
    PMA / PMN Number
    P840064
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT TRENDING WAS REVIEWED FOR THE LOT CODE PROVIDED. TWO SIMILAR COMPLAINTS WERE FOUND. RETURNED PRODUCT CANNOT CONFIRM THIS COMPLAINT INDICATION. THE COMPLAINT CONDITION COULD NOT BE CONFIRMED AS THE INDICATED PROBLEM CANNOT BE VISUALLY INSPECTED WITH THE RETURNED SAMPLE. BATCH RECORDS WERE REVIEWED AND ALL TESTING RESULTS MET SPECIFICATIONS FOR THIS LOT CODE AT THE TIME OF RELEASE. ADDITIONALLY, THERE WERE NO DEVIATIONS NOTED DURING BATCH RECORD REVIEW. REVIEW OF THE BATCH RECORD INDICATES THE PRODUCT MEETS SPECIFICATION. NO MANUFACTURING ASSIGNABLE ROOT CAUSE COULD BE DETERMINED. THERE IS NO IMPACT TO SAFETY, QUALITY, OR EFFICACY OF THE PRODUCT. BASED ON THE INVESTIGATION, THE LACK OF ADDITIONAL COMPLAINTS FOR THIS LOT, THE RETURNED SAMPLE EVALUATION, AND THE ACCEPTABLE BATCH RECORD REVIEW, NO FURTHER ACTION IS WARRANTED AT THIS TIME. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 1

    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. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED AN "OUTBREAK" OF TOXIC ANTERIOR SEGMENT SYNDROME (TASS) AT THEIR FACILITY. IN A FOLLOW UP WITH THE CUSTOMER, IT WAS REPORTED THAT THERE WERE FOUR PATIENTS WHO PRESENTED WITH TASS FOLLOWING OCULAR SURGERY. THERE WERE TWO SURGEON'S INVOLVED. ALL FOUR OF THE TASS CASES ALSO HAD GLAUCOMA AND THREE OF THE PATIENT'S HAD COMBINED CATARACT AND GLAUCOMA PROCEDURE. IT IS UNKNOWN AT THIS TIME WHICH SURGERY WAS PERFORMED ON WHICH PATIENT. THIS FILE REPRESENTS ONE OF THE FOUR PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    657611 DUOVISC OPHTHALMIC VISCOSURGICAL DEVICE AID, SURGICAL, VISCOELASTIC LZP LIFECORE BIOMEDICAL, LLC NA 028957 00380651831353

    Patients

    Seq Age Sex Outcome Treatment
    1 Other CENTURION SURGICAL PROCEDURE PAK| CENTURION VISION SYSTEM| PROVISC OPHTHALMIC VISCOSURGICAL DEVICE| CENTURION SURGICAL PROCEDURE PAK| CENTURION VISION SYSTEM| PROVISC OPHTHALMIC VISCOSURGICAL DEVICE