BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROVISC OPHTHALMIC VISCOSURGICAL DEVICE

    MDR report key: 11718441 · Received April 23, 2021

    Report

    Report Number
    2184002-2021-00005
    Event Type
    Injury
    Date Received
    April 23, 2021
    Date of Event
    March 29, 2021
    Report Date
    July 12, 2021
    Manufacturer
    LIFECORE BIOMEDICAL, LLC
    Product Code
    LZP
    UDI-DI
    00380651830851
    PMA / PMN Number
    P890047
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION IS PROVIDED IN D.4, D.9, H.3, H.4, H.6 AND H.10. A SAMPLE HAS BEEN RECEIVED. COMPLAINT INDICATION CANNOT BE VISUALLY INSPECTED. THIS RETURNED PRODUCT CANNOT CONFIRM THIS COMPLAINT INDICATION. COMPLAINT TRENDING REVIEWED FOR THE LOT CODE PROVIDED. TWO SIMILAR COMPLAINTS FOUND. 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 WARRANTED AT THIS TIME. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 1

    NO SAMPLE HAS BEEN RECEIVED BY MANUFACTURING FOR EVALUATION. 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. THIS IS SEVEN OF SEVEN REPORTS FOR THIS REPORTED EVENT. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED AN "OUTBREAK" OF 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 PATIENTS ASSOCIATED WITH THIS REPORT OF TASS HAD A HISTORY OF GLAUCOMA. THE EXACT PROCEDURE PERFORMED ON ANY ONE PATIENT REMAINS UNCONFIRMED. THIS FILE REPRESENTS TWO OUT OF THE FOUR PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610249 PROVISC OPHTHALMIC VISCOSURGICAL DEVICE AID, SURGICAL, VISCOELASTIC LZP LIFECORE BIOMEDICAL, LLC NA 028876 00380651830851

    Patients

    Seq Age Sex Outcome Treatment
    1 Other