BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTI-FREE REPLENISH

    MDR report key: 2063758 · Received April 14, 2011

    Report

    Report Number
    1610287-2011-00039
    Event Type
    Injury
    Date Received
    April 14, 2011
    Date of Event
    January 14, 2011
    Report Date
    March 15, 2011
    Manufacturer
    ALCON - FORTH WORTH / ALCON LABORATORIES, INC.
    Product Code
    LPN
    PMA / PMN Number
    K050729
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE SAMPLE WAS RETURNED BY THE CUSTOMER. A VISUAL EXAMINATION OF THE EXTERIOR OF THE RETURNED SAMPLE SHOWED DUST AND HAIR ON THE CAP AND SHOULDER OF THE BOTTLE WHICH MAY INDICATE POOR LENS CARE PRACTICES. THE CAP WAS REMOVED TO OBSERVE THE SOLUTION, THE SOLUTION APPEARED TO HAVE NO VISIBLE PARTICULATES, AND HAD TYPICAL ODOR, COLORING AND CLARITY. THE COMPLAINT HISTORY WAS REVIEWED FOR THIS LOT AND THERE WERE TWO OTHER COMPLAINTS FOR EYE IRRITATION REPORTED. REVIEW OF THE COMPOUNDING AND FILLING MBRS 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. ADD'L INFO WAS REQUESTED BY FAX AND MAIL ON 02/10/2011 AND 03/21/2011 AND BY PHONE ON 02/22/2011 AND 02/28/2011. A COMPLETED QUESTIONAIRE WAS RECEIVED FROM THE CONSUMER ON 03/15/2011 AND FROM THE DOCTOR ON 03/22/2011. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT SHE EXPERIENCED INFLAMED CORNEAS FOLLOWING USE OF THIS PRODUCT. SHE STATED HER DOCTOR TREATED WITH AN UNSPECIFIED STEROID EYE DROP AND ARTIFICIAL TEARS. ON (B)(6) 2011, THE CONSUMER'S HUSBAND REPORTED THAT THE EVENT HAD RESOLVED. ON (B)(6) 2011, A COMPLETED QUESTIONAIRE WAS RECEIVED FROM THE CONSUMER WHERE SHE REPORTED HER VISION WAS SEVERELY IMPAIRED, BLURRED AND CORNEAS WERE SEVERELY INFLAMED. THE CONSUMER REPORTED THE EVENT LASTED 21 DAYS AND RESOLVED WITH TREATMENT. ON (B)(6) 2011, A QUESTIONAIRE WAS RECEIVED FROM THE OPTOMETRIST WHO DESCRIBED THE EVENT AS CHEMICAL KERATITIS AND BLURRED VISION. HE REPORTED THAT HE CONSIDERED THE EVENT TO BE MODERATE IN SEVERITY AND WAS RESOLVING AT THIS TIME. HE TREATED THE PT WITH AN ANTIBIOTIC/STEROID AND ARTIFICIAL TEAR PRODUCT AND CHANGED HER TO ANOTHER CONTACT LENS SOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTI-FREE REPLENISH LENS CARE DISINFECTING SOLUTIONS LPN ALCON - FORTH WORTH / ALCON LABORATORIES, INC. NA 178753F

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other SYNTHROID 100MCG QD - (12 YEARS)| SOFTLENS CONTACT| SL 66 TORIC