BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOTRUE MULTI-PURPOSE SOLUTION

    MDR report key: 6112785 · Received November 18, 2016

    Report

    Report Number
    0001313525-2016-00609
    Event Type
    Injury
    Date Received
    November 18, 2016
    Date of Event
    October 19, 2016
    Report Date
    October 19, 2016
    Manufacturer
    BAUSCH & LOMB INCORPORATED
    Product Code
    LYL
    PMA / PMN Number
    K083757
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    TREATING DOCTOR REPORTED THAT THE COMPLAINT DEVICE CAUSED OR CONTRIBUTED TO THE EVENT, HOWEVER, THE COMPLAINT SAMPLE WAS RETURNED FOR EVALUATION AND THE RESULTS OF THE TESTING PERFORMED WERE ALL WITHIN SPECIFICATION. ADDITIONALLY, A REVIEW OF THE LOT BATCH RECORD CONCLUDED THAT THIS PRODUCT WAS FORMULATED AND MANUFACTURED ACCORDING TO LOCAL AND GLOBAL SPECIFICATIONS. BASED ON AVAILABLE INFORMATION, NO CAUSAL FACTORS CAN BE DETERMINED AND NO CONCLUSION CAN BE DRAWN.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT SAMPLE WAS RETURNED AND IS CURRENTLY PENDING EVALUATION. A REVIEW OF THE LOT DEVICE HISTORY RECORDS IS ONGOING. BASED ON AVAILABLE INFORMATION, NO CAUSAL FACTORS CAN BE DETERMINED AND NO CONCLUSION CAN BE DRAWN.

    Additional Manufacturer Narrative · 1

    BASED ON AVAILABLE INFORMATION, NO CAUSAL FACTORS CAN BE DETERMINED AND NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    SINCE THE INITIAL REPORT DATED 18-NOV-2016, INFORMATION OBTAINED FROM THE HEALTHCARE PROVIDER INDICATES THE PATIENT WAS DIAGNOSED WITH BILATERAL CHEMICAL CONJUNCTIVITIS. PER TREATING DOCTOR, PATIENT VISITED EMERGENCY DEPARTMENT WITH BILATERAL EYE INJECTION AND TEARING. PATIENT STATED THAT HER SYMPTOMS BEGAN AFTER USING THE CONTACT LENS SOLUTION IN QUESTION. PATIENT WAS PRESCRIBED ERYTHROMYCIN OPHTHALMIC OINTMENT AND TOBRAMYCIN EYE DROPS. DOCTOR REPORTED PATIENT IS COMPLIANT WITH LENS WEAR AND CARE. THE DOCTOR REPORTED THAT THERE WAS NO PERMANENT DAMAGE AND NOTED THAT THE PATIENT IS RECOVERED. WHILE MEDICAL DOCUMENTATION INDICATES PATIENT IS RECOVERED, PATIENT REPORTS HER EYES TO STILL BE RED AND DRY.

    Description of Event or Problem · 1

    CONSUMER REPORTED EXPERIENCING PAIN, BLURRED VISION, AND REDNESS UPON INITIAL USE OF PRODUCT. CONSUMER REPORTED VISITING EMERGENCY ROOM AND BEING DIAGNOSED WITH CHEMICAL CONJUNCTIVITIS IN BOTH EYES. CONSUMER WAS PRESCRIBED TOBRAMYCIN .3% OPHTHALMIC SOLUTION AND INSTRUCTED TO FOLLOW-UP WITH HER EYE CARE PROFESSIONAL. THE CONSUMER HAS NOT PROVIDED UPDATE ON CONDITION AND HAS NOT PROVIDED INDICATION OF FOLLOW-UP. MEDICAL RECORDS HAVE BEEN REQUESTED BUT HAVE NOT BEEN RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION OBTAINED INDICATES THAT THE CONSUMER FOLLOWED-UP AT AN EYE CLINIC TWO DAYS FOLLOWING HER VISIT TO THE EMERGENCY ROOM. OPTOMETRIST WHO SAW PATIENT AT EYE CLINIC INFORMED THAT THE PATIENT WAS SEEN IN THE EMERGENCY ROOM FOR SYMPTOMS OF OCULAR BURNING, REDNESS, DISCHARGE, AND BLURRED VISION. PATIENT WAS TREATED AND INSTRUCTED TO FOLLOW-UP WITH THE CLINIC. AT TIME OF HER FOLLOW-UP VISIT, THE PATIENT PRESENTED WITH BURNING, DISCHARGE, REDNESS, AND BLURRED VISION. OPTOMETRIST DIAGNOSED CHEMICAL CONJUNCTIVITIS. IT WAS NOTED THAT THE CORNEA WAS NOT INVOLVED AND THAT THE EXAMINATION WAS NORMAL. PATIENT¿S EYES APPEARED STABLE AND OPTOMETRIST RECOMMENDED PATIENT DISCONTINUE THE MEDICATION PROVIDED BY THE EMERGENCY ROOM. OPTOMETRIST NOTED THAT THE PATIENT WAS CONVINCED THAT HER SYMPTOMS WERE SECONDARY TO THE CONTACT LENS SOLUTION IN QUESTION AND STATED THAT THE TIMING WAS COMPELLING. PATIENT WAS THEN SEEN TWO WEEKS LATER FOR A COMPREHENSIVE EYE EXAMINATION AND THERE WERE NO RESIDUAL EFFECTS. FOUR MONTHS LATER, CONSUMER VISITED AN ALTERNATE EYE CLINIC. INFORMATION OBTAINED FROM THIS CLINIC INDICATES THAT THE PATIENT WAS SEEN WITH SYMPTOMS OF FLOATERS IN BOTH EYES. CORNEA WAS NOT INVOLVED. DOCTOR DIAGNOSED BILATERAL VITREOUS DEGENERATION AND BILATERAL MYOPIA. PATIENT WAS ONLY SEEN ONCE AT THIS CLINIC AND WAS NOT PROVIDED WITH ANY MEDICAL INTERVENTION. DOCTOR OPINED THAT THE LIKELY CAUSE OF THE EVENT WAS AGE RELATED VITREOUS DEGENERATION. CLINIC ALSO NOTED THAT THE PATIENT HAS A HISTORY OF VITREOUS DEGENERATION AND MYOPIA. BOTH DOCTORS INDICATED THAT THE EVENT WAS NOT CONSIDERED LIFE THREATENING, DID NOT RESULT IN PERMANENT DAMAGE TO A BODY STRUCTURE, AND DID NOT NECESSITATE MEDICAL/SURGICAL INTERVENTION IN ORDER TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765902 BIOTRUE MULTI-PURPOSE SOLUTION ACCESSORIES, SOLUTION, CLEANERS FOR LENSES LYL BAUSCH & LOMB INCORPORATED GF16073

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other