BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTI-FREE REPLENISH

    MDR report key: 1936656 · Received December 17, 2010

    Report

    Report Number
    1610287-2010-00152
    Event Type
    Injury
    Date Received
    December 17, 2010
    Report Date
    November 19, 2010
    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 CAN BE CONDUCTED AT THIS TIME. THIS DOES NOT APPEAR TO BE A REPORTABLE MALFUNCTION. NO ROOT CAUSE COULD BE DETERMINED. ADDITIONAL INFORMATION WAS REQUESTED VIA PHONE ON 11/22/2010 AND 12/03/2010; VIA FAX ON 11/22/2010; AND VIA MAIL ON 11/22/2010. (B)(4).

    Description of Event or Problem · 1

    INFORMATION PRESENTED AT THE ASSOCIATION FOR RESEARCH IN VISION AND OPHTHALMOLOGY [ARVO], MAY 2-6, 2010, BY AN OPTOMETRIST, INDICATED 45 PATIENTS WITH CORNEAL INFILTRATIVE EVENTS FOLLOWING THE USE OF THIS PRODUCT. THE OPTOMETRIST REPORTED THE PATIENTS PRESENTED WITH ACUTE PAIN, REDNESS, PHOTOPHOBIA, CORNEAL INFILTRATES, AND DECREASED VISION. HE NOTED THE INFILTRATES APPEARED CENTRAL AND NUMEROUS. HE STATED 20 EYES HAD VISUAL ACUITY LOSS OF 20/40 OR GREATER WITH 6 OR MORE INFILTRATES AND CONJUNCTIVAL REDNESS GRADE 2+. HE STATED 6 EYES HAD 2+ ANTERIOR CHAMBER REACTIONS WITH 3 OR MORE INFILTRATES. HE REPORTED THE PATIENTS' SYMPTOMS HAVE RESOLVED WITH THE TREATMENT OF CORTICOSTEROIDS AND ARTIFICIAL TEARS. ON 12/03/2010, ADDITIONAL INFORMATION WAS RECEIVED FROM THE OPTOMETRIST STATING SINCE 2008 TO THE PRESENT, HE NOW HAS APPROXIMATELY 60 PATIENTS WITH CORNEAL INFILTRATIVE EVENTS FOLLOWING THE USE OF THIS PRODUCT AND SILICONE-CONTAINING HYDROGEL CONTACT LENSES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    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 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 35 OF THE 45 PATIENTS THAT WERE USING THIS PRODUCT| CONTAINING HYDROGEL CONTACT LENSES.| WERE WEARING VISTAKON SENOFILCON A SILICONE-