BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTI-FREE REPLENISH

    MDR report key: 2593502 · Received May 25, 2012

    Report

    Report Number
    1610287-2012-00074
    Event Type
    Injury
    Date Received
    May 25, 2012
    Date of Event
    July 21, 2011
    Report Date
    January 27, 2012
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: NO LOT CODE WAS REPORTED OR SAMPLE PROVIDED BY THE CUSTOMER FOR THIS COMPLAINT. NO ROOT CAUSE CAN BE DETERMINED. ADDITIONAL INFORMATION WAS REQUESTED ON 01/31/2012, 02/15/2012, AND 02/23/2012 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 04/25/2012. (B)(4).

    Description of Event or Problem · 1

    AN ASSISTANT REPORTED A PATIENT WITH SUPERFICIAL PUNCTATE KERATITIS FOLLOWING THE USE OF THIS PRODUCT. IN A FOLLOW UP, THE OPHTHALMOLOGIST REPORTED THE PATIENT HAD RED EYES AND KERATITIS SECONDARY TO CONTACT LENS WEAR. THE PATIENT WAS TREATED WITH STEROID DROPS AND DISCONTINUED CONTACT LENS WEAR FOR TWO WEEKS. THE EVENT RESOLVED WITH TREATMENT.

    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 38 YR Required Intervention ACUVUE WITH ASTIGMATIC LENSES| MULTIVITAMINS - 1 TABLET DAILY