BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOTRUE MULTI-PURPOSE SOLUTION(MILAN)

    MDR report key: 14801602 · Received June 24, 2022

    Report

    Report Number
    0001313525-2022-00086
    Event Type
    Injury
    Date Received
    June 24, 2022
    Date of Event
    May 25, 2022
    Report Date
    May 30, 2022
    Manufacturer
    BAUSCH & LOMB INCORPORATED
    Product Code
    LYL
    PMA / PMN Number
    K083757
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE WAS REQUESTED, BUT NOT RECEIVED. THIS EVENT OCCURRED IN GERMANY WHERE THIS DEVICE HAS BEEN VOLUNTARY RECALLED. THE DEVICE INVOLVED IN THIS VOLUNTARY RECALL HAS NOT BEEN DISTRIBUTED TO THE UNITED STATES. BASED ON ALL AVAILABLE INFORMATION, NO CAUSAL FACTORS CAN BE DETERMINED AND NO CONCLUSION CAN BE DRAWN.

    Additional Manufacturer Narrative · 0

    DEVICE WAS RETURNED FOR EVALUATION. THE RESULTS OF THAT EVALUATION REVEALED THAT THE SOLUTION MET ALL CHEMICAL SPECIFICATION REQUIREMENTS AND CONCLUDED THAT NO PRODUCT DEFECT WAS FOUND. BASED ON ALL AVAILABLE INFORMATION, NO CAUSAL FACTORS CAN BE DETERMINED AND NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 0

    A CONSUMER REPORTED THAT THEIR SPOUSE USED A NEW BOTTLE OF THE LENS CARE SOLUTION TO STORE THEIR CONTACT LENSES. THE FOLLOWING MORNING, AFTER INSERTING THE LENSES, THEY EXPERIENCED SLIGHT BURNING OF BOTH EYES, BLURRY VISION AND THEY WERE UNABLE TO OPEN THEIR EYES. THEY WASHED THEIR EYES OUT WITH AN UNKNOWN SUBSTANCE WITH NO RELIEF. THE PATIENT VISITED THEIR OPHTHALMOLOGIST AND WAS DIAGNOSED WITH A CORNEAL BURN AND REFERRED TO A HOSPITAL WHERE THEY WERE TREATED FOR TWO DAYS. MEDICAL RECORDS WERE RECEIVED FROM THE HOSPITAL INDICATES THE PATIENT WAS SEEN ON HOSPITAL ADMISSION WITH VISUAL ACUITY OF RIGHT EYE 0.4 AND LEFT 0.2. EXAMINATION SHOWED THE RIGHT EYELID WAS FREE OF IRRITATION. THE CONJUNCTIVA WAS INJECTED, CENTRAL (1.5MM) CORNEAL EROSION, ANTERIOR CHAMBER WAS FREE, DEEP AND PUPILS WERE ROUND. LEFT EYE SHOWED THE LID WAS IRRITATION FREE, WITH THE CONJUNCTIVA INJECTED, CORNEA WAS ''WHITISH'', THE ANTERIOR CAMBER WAS FREE, DEEP, AND THE PUPIL WAS ROUND. THE PATIENT WAS DIAGNOSED WITH GRADE 1 CHEMICAL BURN. THE PATIENT WAS TREATED WITH INTENSIVE IRRIGATION THERAPY AND ANTI-INFLAMMATORY LOCAL THERAPY. WHEN THE PATIENT WAS DISCHARGED IT SHOWED THE BOTH EYES HAD THEIR CONJUNCTIVA FREE OF IRRITATION, POSITIVE LID-PARALLEL CONJUNCTIVAL FOLDS, CORNEAL KERATITIS SUPERFICIAL PUNCTATE, ANTERIOR CHAMBER IS DEEP CLEAN WITH ROUND PUPILS. THE LEFT EYE ALSO SHOWED SMALL TEMPORAL EROSIONS. THE PATIENT WAS INSTRUCTED TO USE FLOXAL-AT THREE TIMES DAILY, FLOXAL-AS AT NIGHT AND HYLO-GEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1071508 BIOTRUE MULTI-PURPOSE SOLUTION(MILAN) ACCESSORIES, SOLUTION, CLEANERS FOR LENSES LYL BAUSCH & LOMB INCORPORATED 222

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Hospitalization