BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENU SENS. MULTI-PURPOSE SOL.(MILAN)

    MDR report key: 12617415 · Received October 12, 2021

    Report

    Report Number
    0001313525-2021-00124
    Event Type
    Injury
    Date Received
    October 12, 2021
    Date of Event
    June 10, 2021
    Report Date
    September 13, 2021
    Manufacturer
    BAUSCH & LOMB INCORPORATED
    Product Code
    LPN
    PMA / PMN Number
    K982775
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT WAS RETURNED AND EVALUATED. EVALUATED BIOBURDEN TESTING SHOWS A GROWTH IDENTIFIED AS GRAM-POSITIVE COCCI WAS FOUND INSIDE OF THE TIP CAP. THE SAMPLE WAS INSUFFICIENT TO PERFORM COMPLETE BIOCIDAL TESTING. COMPLETE CHEMICAL TESTING COULD NOT BE PERFORMED DUE TO INSUFFICIENT SAMPLES. HOWEVER, TESTING THAT WAS COMPLETED SHOWED RESULTS THAT WERE WITHIN SPECIFICATION REQUIREMENTS. THE REVIEW OF THE MANUFACTURING PROCESS, QUALITY SYSTEMS, AND PRODUCT CHARACTERISTIC, AND ANALYSIS OF ADVERSE EVENTS, COMPLAINTS AND PROBLEMS SUPPORTS THE PRODUCTS ARE SAFE AND PERFORMING WITHIN ANTICIPATED RATES. BASED ON ALL AVAILABLE INFORMATION, NO CAUSAL FACTORS CAN BE DETERMINED AND NO CONCLUSION CAN BE DRAWN.

    Additional Manufacturer Narrative · 0

    PRODUCT HAS BEEN RETURNED AND IS UNDERGOING EVALUATION. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE MANUFACTURING RECORDS ASSOCIATED WITH THIS LOT FOUND THE PRODUCT MET ALL ACCEPTANCE CRITERIA AT THE TIME OF MANUFACTURE AND DISTRIBUTION. CHEMICAL ANALYSIS ON RETAIN SAMPLES ARE WITHIN THE LIMITS. BIOCIDAL, BIOBURDEN EVALUATION ON RETAIN SAMPLES ARE WITHIN THE LIMITS. BASED ON ALL INFORMATION, NO CAUSAL FACTORS CAN BE DETERMINED AND NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE REPORTER. THE CONSUMER WAS PRESCRIBED AN UNKNOWN EYE DROP AND USED THE DROP FOR APPROXIMATELY TWO WEEKS. THE PATIENT HAS RECOVERED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS NOT BEEN RETURNED. ADDITIONAL EVENT AND MEDICAL INFORMATION HAVE BEEN REQUESTED BUT NOT YET RECEIVED. THIS EVENT OCCURRED IN FRANCE WHERE THIS DEVICE HAS BEEN VOLUNTARY RECALLED. THE DEVICE INVOLVED IN THIS VOLUNTARY RECALL HAS NOT BEEN DISTRIBUTED TO THE UNITED STATES. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    A CONSUMERS SPOUSE REPORTED THAT THE CONSUMER WAS DIAGNOSED WITH A CORNEAL ABSCESS. PER THE SPOUSE, AN OPHTHALMOLOGIST TREATED THE INFECTION WITH A COMBINATION OF UNKNOWN ANTIBIOTICS, WHICH HAS NOT BEEN EFFECTIVE. FOLLOW UP WITH THE REPORTER REVEALED THE CONSUMER EXPERIENCED RED EYE UNTIL THEY VISITED AN OPHTHALMOLOGIST WHO DIAGNOSED THE CONSUMER WITH CORNEAL ABSCESS AND PRESCRIBED WITH AN UNKNOWN ANTIBIOTIC EYEDROP. THEY WERE REFERRED TO ANOTHER OPHTHALMOLOGIST WHO PERFORMED A CULTURE, RESULTS REVEALED THE CONSUMER HAD CANDIDA FUNGUS. THEY ARE CURRENTLY BEING TREATED WITH AMPHOTERICIN B 2 MG/ML (FUNGIZONE B) AND VORICONAZOLE 10 MG/ML EVERY HOUR. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1515146 RENU SENS. MULTI-PURPOSE SOL.(MILAN) ACCESSORIES, SOFT LENS PRODUCTS LPN BAUSCH & LOMB INCORPORATED 222

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention