BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTI-FREE EVERMOIST

    MDR report key: 3770958 · Received December 19, 2013

    Report

    Report Number
    1610287-2013-00046
    Event Type
    Injury
    Date Received
    December 19, 2013
    Date of Event
    November 16, 2013
    Report Date
    November 16, 2013
    Manufacturer
    ALCON - FORT WORTH/ ALCON LABORATORIES, INC.
    Product Code
    LPN
    PMA / PMN Number
    K102860
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE AVAILABLE AT THIS TIME. THE COMPLAINT HISTORY WAS REVIEWED AND THERE WAS NO OTHER COMPLAINTS REPORTED SIMILAR IN NATURE. REVIEW OF THE COMPOUNDING, FILLING AND PACKAGING MANUFACTURING BATCH REVIEWS (MBR) SHOW THEM TO BE ACCEPTABLE. A REVIEW OF THE AVAILABLE STABILITY DATA FOR PUREMOIST FORMULA, CURRENTLY ENROLLED IN THE STABILITY PROGRAM, WAS CONDUCTED AND ALL LOTS REMAIN WITHIN SPECIFICATION. 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. INCOMING COMPONENT TESTING RESULTS WERE REVIEWED AND FOUND TO BE ACCEPTABLE. THIS LOT MET ALL RELEASE CRITERIA PRIOR TO PRODUCT RELEASE. CONSUMER PRODUCT USE AND LENS CARE PRACTICE CANNOT BE CONFIRMED. NO ROOT CAUSE COULD BE DETERMINED HOWEVER THIS REPORT IS CONSISTENT WITH KNOWN ADVERSE EVENTS FOR PUFFY EYES AND BURNING SENSATION INDICATED IN THE PRODUCT LITERATURE. BASED ON THE ACCEPTABLE MBR REVIEW, FINISHED PRODUCT TESTING RESULTS, FINISHED PRODUCT INSPECTION RESULTS, FORMATION STABILITY AND LACK OF NEGATIVE COMPLAINT TREND, THIS LOT CONTINUES TO BE ACCEPTABLE. NO FURTHER ACTION IS WARRANTED AT THIS TIME. THE PRODUCT LITERATURE PROVIDED ON THE INSIDE OF THE OPTI FREE EVERMOIST PUREMOIST CARTON STATES THAT IF YOU ARE ALLERGIC TO ANY INGREDIENT IN THIS PRODUCT, DO NOT USE. IT ALSO LISTS POSSIBLE ADVERSE EVENTS, STATING THAT EYES MAY STING, BURN OR HAVE ITCHING IRRITATION, COMFORT MAY BE LESS THAN WHEN LENS WAS FIRST PLACED ON THE EYE, A FEELING OF SOMETHING IN THE EYE (FOREIGN BODY, SCRATCHED AREA), EXCESSIVE WATERING (TEARING) OF THE EYE, UNUSUAL EYE SECRETIONS, REDNESS OF THE EYE, REDUCED SHARPNESS OF VISION (POOR VISUAL ACUITY), BLURRED VISION, RAINBOWS OR HALOS AROUND OBJECTS, SENSITIVITY TO LIGHT (PHOTOPHOBIA), OR DRY EYES MAY OCCUR AND OFFERS SUGGESTIONS TO RESOLVE. THE LITERATURE ALSO PROVIDES WARNINGS INCLUDING VISION CHANGES, PRECAUTIONS, AND GOOD LENS CARE PRACTICES TO AVOID ANY EYE INJURY OR PRODUCT CONTAMINATION AND TO ENSURE PROPER USE AND STORAGE OF THE PRODUCT. LITERATURE ALSO INCLUDES THE NOTICE THAT THE REUSE OF SOLUTION OR USE OF WATER WITH LENSES MAY LEAD TO CONTAMINATION RESULTING IN EYE INJURY AND POTENTIAL LOSS OF VISION. IMPORTANT SAFETY INFORMATION IS ALSO INCLUDED IN THE LITERATURE, SUCH AS ALWAYS FOLLOW PRODUCT DIRECTIONS FOR USE, FAILURE TO FOLLOW PRODUCT DIRECTIONS MAY LEAD TO VISION LOSS, ALWAYS WASH AND DRY HANDS BEFORE HANDLING LENSES, DO NOT USE TAP WATER, BOTTLED WATER OR SALIVA WITH LENSES OR LENS CASE, DISCARD ANY REMAINING SOLUTION IN YOUR LENS CASE AFTER EACH DISINFECTION CYCLE.(NEVER REUSE SOLUTION) TO AVOID CONTAMINATION, DO NOT TOUCH TIP OF CONTAINER TO ANY SERVICE. RECAP AFTER EACH USING. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED BY THE PATIENT, THEY EXPERIENCED AN ADVERSE REACTION TO OPTI-FREE PURE MOIST. ON (B)(6) 2013, THE PATIENT WENT TO THEIR EYE CARE PROVIDER FOR A FITTING AND WAS GIVEN PURE MOIST WITH CONTACT LENSES. UPON INSERTION, THE PATIENT EXPERIENCED A BURNING SENSATION IN BOTH EYES. LATER THAT DAY, THE PATIENT REMOVED THE LENSES AND STATED THEIR BODY AND FACE WERE EXTREMELY ITCHY AND OBSERVED HIVES, DESCRIBED AS HUGE WELTS. THE PATIENT ATTENDED URGENT CARE AND WAS PRESCRIBED A STEROID. ON (B)(6) 2013, THE PATIENT STARTED PREDNISONE 10MG TABLETS, SIX TABLETS FOR DAY ONE, FIVE TABLETS FOR DAY TWO, FOUR TABLETS ON DAY THREE AND GRADUALLY TAPERED DOWN. THE PATIENT STATED BY (B)(6) 2013 IT WAS WORSE AND THEIR STEROIDS WERE DOUBLED TO 20MG, FOUR TABLETS FOR THREE DAYS, THREE TABLETS FOR THREE DAYS, TWO TABLETS FOR TWO DAYS AND ONE TABLET FOR THE LAST DAY. THE PATIENT WAS GIVEN AN EPINEPHRINE SHOT AND RANITIDINE, 300MG ONE TABLET TWICE DAILY. THE PATIENT WAS ALSO GIVEN AN ANTACID BECAUSE THEY COULDN'T BREATHE DUE TO HEART BURN FROM OTHER MEDICATIONS (OTHER MEDICATIONS UNSPECIFIED). MEDICAL RECORDS PROVIDED BY THE PATIENT ON (B)(6) 2013 ARE CONSISTENT WITH THE PATIENT'S INITIAL REPORT AND FURTHER INDICATE THE PATIENT ALSO COMPLAINED OF EDEMA IN ADDITION THE HIVES AND ALLERGIC REACTION. THE PATIENT EXPERIENCED SIGNIFICANT RELIEF OF THE ITCHY SENSATION AND RASH/SWELLING ON THE FACE AND HANDS. THE PATIENT WAS ADVISED TO FOLLOW UP WITH THEIR PRIMARY CARE PHYSICIAN IN THREE DAYS IF NO IMPROVEMENT WAS NOTED. THE PATIENT STATED THAT IN TWO WEEKS, THE SYMPTOMS HAD RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667711 OPTI-FREE EVERMOIST LENS CARE DISINFECTING SOLUTIONS LPN ALCON - FORT WORTH/ ALCON LABORATORIES, INC. NA 206038F

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other