BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AOSEPT PLUS/CLEAR CARE PLUS WITH HYDRAGLYDE CLEANING AND DISINFECTING SOLUTION

    MDR report key: 17797378 · Received September 22, 2023

    Report

    Report Number
    1610287-2023-00041
    Event Type
    Injury
    Date Received
    September 22, 2023
    Date of Event
    August 23, 2023
    Report Date
    December 20, 2023
    Manufacturer
    ALCON RESEARCH, LLC
    Product Code
    LPN
    UDI-DI
    00300650363402
    PMA / PMN Number
    K142284
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD FOR THIS LOT HAVE BEEN REVIEWED AND FOUND TO BE IN COMPLIANCE. THERE WAS NO NONCONFORMITY OR DEVIATIONS DURING THE MANUFACTURING PROCESS WHICH RELATED TO THE NATURE OF THE COMPLAINT. THE ROOT CAUSE COULD NOT BE DETERMINED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    H.3, H.6: THE COMPLAINT SAMPLE HAS NOT RETURNED 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. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    SAFETY EVENT DESCRIPTION: A CONSUMER EXPERIENCED CONSUMER STATING SHE EXPERIENCED BLURRY VISION, DRY EYE, EYE PAIN, LENS BECAME HARD, RED EYES, CORNEAL ABRASION, DISCOMFORT MADE NOSE CONSTANTLY RUN AND SOUND SICK AND TEARING. ADDITIONAL INFORMATION RECEIVED WITH MEDICAL RECORD STATES THAT THE CONSUMER VISITED DOCTOR AND UNDERWENT EYE EXAMINATION IN WHICH CONSUMER¿S LID MARGIN, ANTERIOR CHAMBER, IRIS, AND LENS WERE NORMAL FOR BOTH EYES. CONJUNCTIVA AND CORNEA WERE NORMAL FOR LEFT EYE. BUT IN RIGHT EYE THE CONSUMER GOT DIAGNOSED WITH CENTRAL RECURRENT CORNEAL EROSION. THE CONSUMER WAS PRESCRIBED WITH MOXIFLOXACIN OPHTHALMIC SOLUTION 0.5% WITH A FREQUENCY OF EVERY HOUR WHILE AWAKE, CARBOXY METHYL CELLULOSE SODIUM EYE DROPS WITH A FREQUENCY OF EVERY NIGHT AT BEDTIME AND SYSTANE COMPLETE EYE DROPS WITH A FREQUENCY OF ONCE IN A DAY IN THE MORNING. THE CONSUMER WAS SUGGESTED TO SCHEDULE A FOLLOW-UP VISIT. THE CONSUMER VISITS ANOTHER DOCTOR AS A FOLLOW-UP VISIT. THE CONSUMER AGAIN UNDERWENT EYE EXAMINATION IN WHICH LID MARGIN, ANTERIOR CHAMBER, IRIS, CONJUNCTIVA, AND LENS WERE NORMAL FOR BOTH EYES. THE DIAGNOSTIC DROPS USED WERE FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE CORNEAL EXAMINATION SHOWED ABNORMAL TEAR BREAKUP TIME, ABNORMAL TBUT (TEAR BREAK UP TIME) 3 SECONDS, LASIK FLAP (LASER-ASSISTED IN SITU KERATOMILEUSIS), POSITIVE PUNCTATE EPITHELIAL EROSIONS AND DIAGNOSED WITH VITREOUS SYNERESIS IN BOTH EYES. THE CONSUMER WAS ADVISED DISCONTINUED MOXIFLOXACIN PRESCRIBED WITH PRESERVATIVE FREE ARTIFICIAL TEARS WITH A FREQUENCY OF FOUR TIMES A DAY AND INCREASED DOSE OF OMEGA SUPPLEMENTS. THE CONSUMER WAS RECOMMENDED TO APPLY WARM COMPRESS TO LIDS ONCE IN A DAY AND TO INCREASE HYDRATION, SLEEP HYGIENE AND COMPUTER STRAIN WITH DECREASED BLINK RATE. THE CONSUMER WAS SUGGESTED TO FOLLOW-UP IN SIX WEEKS. THE CURRENT STATUS OF CONSUMER¿S CONDITION WAS RESOLVED AT THE TIME OF REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104929 AOSEPT PLUS/CLEAR CARE PLUS WITH HYDRAGLYDE CLEANING AND DISINFECTING SOLUTION ACCESSORIES, SOFT LENS PRODUCTS LPN ALCON RESEARCH, LLC NA 11XDD 00300650363402

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female Other OMEGA 3