BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROVISC OPHTHALMIC VISCOSURGICAL DEVICE

    MDR report key: 12763859 · Received November 7, 2021

    Report

    Report Number
    2184002-2021-00015
    Event Type
    Injury
    Date Received
    November 7, 2021
    Date of Event
    September 30, 2021
    Report Date
    December 17, 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
    LA, US
    Reporter Occupation
    NURSE
    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. THIS IS SECOND OF THREE REPORTS FOR THIS REPORTED EVENT. (B)(4).

    Additional Manufacturer Narrative · 0

    NO VALID 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 VALID LOT CODE WAS PROVIDED FOR ANALYSIS. NO ACTION IS WARRANTED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    COMPLAINT TRENDING REVIEWED FOR THE LOT CODE PROVIDED. ONE SIMILAR COMPLAINT FOUND. THERE WAS NO SAMPLE RETURNED FOR EVALUATION. THE COMPLAINT CONDITION COULD NOT BE CONFIRMED. 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. SINCE THE ROOT CAUSE IS LIKELY NOT RELATED TO THE MANUFACTURING PROCESS AND THE REPORT DOES NOT INDICATE A TREND, NO FURTHER ACTIONS ARE RECOMMENDED AT THIS TIME. QUALITY ASSURANCE WILL CONTINUE TO MONITOR AND TREND COMPLAINTS OF THIS TYPE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A NURSE REPORTED THAT A PATIENT EXPERIENCED TOXIC ANTERIOR SEGMENT SYNDROME (TASS). PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT AFTER A CATARACT SURGERY, THE PATIENT EXPERIENCED TASS IN THE RIGHT EYE. THE PATIENT HAD NO SURGICAL COMPLICATIONS. THE PATIENT PRESENTED POST-OPERATIVELY WITH NO SIGNS OF SYMPTOMS. UPON EXAMINATION OF THE PATIENT, THE SURGEON NOTED 4+ AQUEOUS CELL. THE PATIENT WAS PRESCRIBED WITH POST-OPERATIVE ANTIBIOTIC AND STEROID EYE DROPS. NO CULTURES WERE PERFORMED. THE PATIENT'S OUTCOME WAS UNKNOWN. THIS FILE REPRESENT THE FIRST PATIENT OF THREE FROM THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1661205 PROVISC OPHTHALMIC VISCOSURGICAL DEVICE AID, SURGICAL, VISCOELASTIC LZP LIFECORE BIOMEDICAL, LLC NA 029018 00380651830851

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female Other BSS IRRIGATING SOLUTION| ILEVRO DROPS| OFLOXACIN| POVIDONE IODINE 5%| RAY ONE ASPHERIC IOL 19.0 D| VANCOMYCIN IN BSS