BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTI-FREE REPLENISH

    MDR report key: 2000754 · Received February 17, 2011

    Report

    Report Number
    1610287-2011-00010
    Event Type
    Injury
    Date Received
    February 17, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: NO LOT CODE OR SAMPLE WAS PROVIDED BY THE CUSTOMER. NO FURTHER EVALUATION OR ROOT CAUSE ANALYSIS CAN BE CONDUCTED OR DETERMINED AT THIS TIME. A COMPLETED QUESTIONNAIRE AND PT MEDICAL RECORDS WERE RECEIVED FROM THE OPTOMETRIST ON 01/18/2011. (B)(4).

    Description of Event or Problem · 1

    AN OPTOMETRIST REPORTED PT EXPERIENCED PAIN, BURNING, ITCHING, TEARING AND REDNESS FOLLOWING THE USE OF THIS PRODUCT. HE STATED THE PT WAS SEEN FOR FOLLOW-UP THE NEXT DAY AND WAS STILL EXPERIENCING BURNING AND PHOTOPHOBIA. HE REPORTED HE DIAGNOSED THE PT WITH ACUTE CORNEAL INFILTRATES WITH A RED EYE RESPONSE. HE NOTED HE TREATED THE PT WITH AN ANTIBIOTIC ANTIFUNGAL OPHTHALMIC MEDICATION FOR ONE WEEK AND DISCONTINUED CONTACT LENS USE. HE REPORTED THE PT'S SYMPTOMS ARE RESOLVING.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Other ACUVUE OASYS CONTACT LENSES