BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTI-FREE REPLENISH

    MDR report key: 2230731 · Received August 17, 2011

    Report

    Report Number
    1610287-2011-00081
    Event Type
    Injury
    Date Received
    August 17, 2011
    Date of Event
    July 17, 2011
    Report Date
    July 18, 2011
    Manufacturer
    ALCON - FORT WORTH/ALCON LABORATORIES, INC.
    Product Code
    LPN
    PMA / PMN Number
    K050729
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE COMPLAINT DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RECEIVED FOR EVALUATION. THE COMPLAINT HISTORY WAS REVIEWED FOR LOT 189012F AND THERE WAS ONE OTHER COMPLAINT OF THIS NATURE REPORTED. REVIEW OF THE COMPOUNDING AND FILING (B)(4) DID NOT SHOW ANY ANOMALIES THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE CHEMISTRY AND MICROBIAL FINISHED PRODUCT RESULTS WERE REVIEWED AND FOUND TO BE ACCEPTABLE. THE ENVIRONMENTAL, UTILITY, BIOBURDEN, AND SANITIZATION RECORDS WERE REVIEWED AND FOUND TO BE ACCEPTABLE. THIS LOT MET ALL RELEASE CRITERIA PRIOR TO PRODUCT RELEASE. BASED ON THE (B)(4) REVIEWS, ACCEPTABLE FINISHED PRODUCT TESTING RESULTS, AND THE LACK OF A NEGATIVE COMPLAINT TREND, THIS LOT CONTINUES TO BE ACCEPTABLE. ADDITIONAL INFORMATION WAS REQUESTED ON (B)(6) 2011. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CONSUMER ON (B)(6) 2011. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED EXPERIENCING A CHEMICAL BURN, SWELLING AND A BURNING SENSATION WITH USE OF THIS PRODUCT FOR THE FIRST TIME. SHE STATED THAT WHEN SHE INITIALLY PUT HER CONTACTS IN THEY FELT FOGGY, LIKE A COATED FILM WAS ON THEM. SHE USED MORE OF THE PRODUCT AND STATED SHE BEGAN TO HAVE A HEADACHE AND AFTER TAKING A NAP, IT FELT LIKE ACID WAS IN HER EYES. SHE INDICATED SHE CALLED THE PARAMEDICS AND WAS TAKEN TO A HOSPITAL WHERE HER EYES WERE FLUSHED FOR ABOUT 45 MINUTES. SHE WAS PRESCRIBED CORTICOSTEROID/ANTIBIOTIC EYE DROPS AND A PAIN MEDICATION FOR THE CHEMICAL BURN. ON (B)(6) 2011, THE CONSUMER PROVIDED ADDITIONAL INFORMATION STATING THE PARAMEDICS RINSED HER EYES FOR TEN MINUTES WITHOUT IMPROVEMENT. SHE INDICATED THAT LIGHT BOTHERED HER EYES AND NUMBING DROPS WERE USED IN THE EMERGENCY ROOM TO OPEN HER EYES. HER EYES WERE THEN RINSED FOR ABOUT 20 MINUTES PER EYE BUT THEY HAD TO STOP DURING THIS PROCESS BECAUSE OF INFLAMMATION AND PAIN. A DYE WAS PUT IN HER EYES AND A SUSPECTED SCRATCH WAS NOT OBSERVED. AN OPHTHALMOLOGIST WAS CALLED IN WHO DIAGNOSED CHEMICAL CONJUNCTIVITIS. SHE REPORTED THAT THE SYMPTOMS RESOLVED WITH TREATMENT AND DISCONTINUATION OF PRODUCT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTI-FREE REPLENISH LENS CARE DISINFECTING SOLUTIONS LPN ALCON - FORT WORTH/ALCON LABORATORIES, INC. NA 189012F

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other DEFINITION AC CONTACT LENSES (DATES UNKNOWN)