BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTI-FREE REPLENISH

    MDR report key: 1825674 · Received September 1, 2010

    Report

    Report Number
    1610287-2010-00109
    Event Type
    Injury
    Date Received
    September 1, 2010
    Date of Event
    July 1, 2010
    Report Date
    August 2, 2010
    Manufacturer
    ALCON - FORT WORTH / ALCON LABS 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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR EVAL. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MFG DOCUMENTATION. ADDITIONAL INFO WAS REQUESTED VIA MAIL ON 08/05/2010 AND 08/23/2010; VIA E-MAIL ON 08/05/2010 AND 08/23/2010; VIA FAX ON 08/23/2010; AND VIA PHONE ON 08/23/2010. ADDITIONAL INFO HAS BEEN REQUESTED FROM THE CONSUMER AND THE OPHTHALMOLOGIST. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "UVEITIS IN BOTH EYES" (UVEITIS); "EXCESSIVE TEARING" (TEARING, EXCESSIVE); "NOT ABLE TO SEE CLEARLY" (VISION, IMPAIRED). PRODUCT PROBLEM(S): "NONE REPORTED" (NO INFO). A CONSUMER REPORTED SHE DEVELOPED UVEITIS AND EXCESSIVE TEARING ELEVEN DAYS FOLLOWING THE USE OF THIS PRODUCT. SHE STATED LESS THAN A MONTH AFTER HAVING AN EYE EXAM, SHE DECIDED TO GET CONTACTS. SHE REPORTED HER OPTOMETRIST PROVIDED HER A TRIAL PAIR OF CONTACT LENSES AND THIS PRODUCT. SHE STATED ELEVEN DAYS LATER, AT A CONTACTS RECHECK VISIT, SHE WAS DIAGNOSED WITH UVEITIS IN BOTH EYES. SHE NOTED THE OPTOMETRIST CONSULTED WITH AN OPHTHALMOLOGIST WHO FELT THE UVEITIS WAS SYSTEMIC IN ORIGIN AND ORDERED BLOOD WORK AND A CHEST X-RAY TO DETERMINE THE HEALTH ISSUE INVOLVED. SHE REPORTED THE TESTS WERE NORMAL AND HER DOCTORS COULD NOT FIND A CAUSE FOR THE UVEITIS. SHE STATED SHE HAS DISCONTINUED USE OF THE PRODUCT AND HER EYES HAVE STARTED TO IMPROVE OVER THE LAST THREE WEEKS. SHE REPORTED HER SON IS NOW USING THIS BOTTLE OF SOLUTION WITHOUT ANY PROBLEMS. ADDITIONAL INFO HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS IS THE FIRST OF TWO REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTI-FREE REPLENISH LENS CARE DISINFECTING SOLUTIONS LPN ALCON - FORT WORTH / ALCON LABS INC NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ACUVUE OASYS FOR ASTIGMATISM SOFT CONTACT LENSES