BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTI-FREE REPLENISH

    MDR report key: 1243057 · Received November 21, 2008

    Report

    Report Number
    1610287-2008-00046
    Event Type
    Injury
    Date Received
    November 21, 2008
    Report Date
    October 27, 2008
    Manufacturer
    ALCON - FORT WORTH ASPEC /ALCON LABORATORIES, INC.
    Product Code
    LPN
    PMA / PMN Number
    K050729
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE COMPLAINT DEVICE ASSOCIATED WITH THIS COMPLAINT WAS NOT RECEIVED FOR EVALUATION. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER HAS NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. THE OPTOMETRIST DECLINED CONSENT TO PROVIDE ADDITIONAL INFORMATION ON QUESTIONNAIRES MAILED TO HIM. ADDITIONAL INFORMATION IS NOT EXPECTED.

    Description of Event or Problem · 1

    AN OPTOMETRIST REPORTED HE HAS HAD APPROXIMATELY FIVE PATIENTS PRESENT WITH CORNEAL ULCERS WHILE USING THIS PRODUCT. HE STATED THE ULCERS STAINED WITH SODIUM FLUORESCEIN AND DESCRIBED THEM AS 1-2MM IN DIAMETER, PERIPHERAL, AND INFECTIOUS. HE REPORTED THE PATIENTS DEVELOPED THE CORNEAL ULCERS WITHIN 6-9 MONTHS OF USING THIS PRODUCT AND SOME OF THE ULCERS RESULTED IN SCARS. THE OPTOMETRIST STATED HE DISCONTINUED THE PATIENT'S CONTACT LENSWEAR FOR APPROXIMATELY ONE WEEK WHILE TREATING THEM WITH OPHTHALMIC ANTIBIOTIC DROPS. HE REPORTED WHEN THE EVENTS RESOLVED, HE DID NOT CHANGE THEIR CONTACT LENS OR LENS CARE SOLUTION, BUT REITERATED COMPLIANCE TO THEM. HE STATED THE PATIENTS WERE ON O2OPTIX SOFT CONTACT LENSES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention O2OPTIX SOFT CONTACT LENSES