BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLEAR CARE

    MDR report key: 11901115 · Received May 28, 2021

    Report

    Report Number
    1610287-2021-00013
    Event Type
    Injury
    Date Received
    May 28, 2021
    Date of Event
    December 7, 2018
    Report Date
    June 15, 2021
    Manufacturer
    ALCON RESEARCH, LLC
    Product Code
    LPN
    PMA / PMN Number
    K031521
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H.3., H.6.: THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD AND STERILIZATION 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 · 1

    THE COMPLAINT SAMPLE HAS NOT RETURNED FOR EVALUATION; THE LOT NUMBER IS UNKNOWN. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    AS INITIALLY REPORTED BY THE FEMALE CONSUMER VIA WEBSITE ON 29FEB2020 AND THE FOLLOW UP INFORMATION RECEIVED ON 16MAY2021. IT WAS STATED THAT ON (B)(6) 2018, OPHTHALMOLOGY IMPRESSION SHOWS, THAT CONSUMER USES LENSES CARED WITH LENS CARE SOLUTION AND WAS FINE ALL DAY. IT WAS ALSO REPORTED THAT TOOK THEM EVENING AND FELT SORE IN EYES AND LATER THAT NIGHT SHE WOKE UP IN SEVERE PAIN. ON (B)(6) 2018, THE CONSUMER COMPLAINED OF PAINFUL EYES, WORSENING WITH EYE MOMENTS, CONSTANT BURNING ASSOCIATED WITH TEARING, HEADACHE, NAUSEA, BLURRED VISION AND SENSITIVE TO LIGHT. ON THE SAME DAY PATIENT WAS DIAGNOSED WITH CORNEAL ABRASIONS ON BOTH EYES. OPHTHALMOLOGY IMPRESSION SHOWS CHEMICAL BURN OF CONJUNCTIVAL SAC OF LEFT EYE AND BILATERAL PUNCTATE KERATITIS AND WAS TREATED WITH ARTIFICIAL TEARS, ANTIBIOTIC EYE DROPS FOR EVERY 2TIMES A DAY FOR SEVERAL DAYS. ON THE SAME DAY STAINING RESOLVED ON (B)(6) 2018, A FOLLOW UP VISIT STATES THAT THE PAINFUL EYES ARE STARCHED CORNEA OU AND ASSOCIATED WITH PHOTOPHOBIA WITH SEVERE IN INTENSITY ON BOTH EYES. ON THE SAME DAY SLIT LAMP EXAMINATION OF CORNEA SHOWED TRACES OF CORNEAL EDEMA AND WAS TREATED WITH ANTIBIOTIC EYE DROPS. ON (B)(6) 2018, PATIENT STATES VISION WAS STILL FUZZY, BLURRY, VERY LIGHT SENSITIVE AND ABOVE EYELIDS HURT AND ALSO STATES THAT SHE WAS DIZZY, NAUSEOUS AND HEADACHE. PATIENT WAS TREATED WITH ANTIBIOTIC EYE DROPS. ON (B)(6) 2018, CONSUMER STATES THAT HER DOCTOR THINKS THE NEUTRALIZER DID NOT WORK FOR THE CLEAR CARE SOLUTION SO EXPERIENCED BURNING AND STATES THAT EYE SORE, EPI INTACT ON THE SAME DAY CONSUMER WAS DIAGNOSED WITH CENTRAL CORNEAL OPACITY ON RIGHT EYE WITH FAINT SCAR AND BILATERAL PUNCTATE KERATITIS. THE PATIENT WAS TREATED WITH NONSTEROIDAL ANTI INFLAMMATORY AND ANTICHOLINERGICS DRUGS ON (B)(6) 2019, STATES NO LONGER PAIN. CONSUMER WAS TREATED WITH NONSTEROIDAL ANTI INFLAMMATORY DRUGS, ANTICHOLINERGICS DRUGS AND STEROID MEDICATION. SYMPTOMS ARE NOT YET RESOLVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797102 CLEAR CARE ACCESSORIES, SOFT LENS PRODUCTS LPN ALCON RESEARCH, LLC NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention