BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTI-FREE REPLENISH

    MDR report key: 1828551 · Received September 3, 2010

    Report

    Report Number
    1610287-2010-00115
    Event Type
    Injury
    Date Received
    September 3, 2010
    Date of Event
    January 1, 2007
    Report Date
    August 6, 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
    FL, 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. ADD'L INFO WAS REQUESTED VIA MAIL ON 08/06/2010, 08/23/2010 AND 08/27/2010; VIA FAX ON 08/23/2010; AND VIA PHONE ON 08/23/2010, 08/30/2010 AND 08/31/2010. ADD'L INFO HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "EYE INFECTION" (INFECTION); "ALLERGIC CONJUNCTIVITIS" (CONJUNCTIVITIS). PRODUCT PROBLEM(S): "NONE REPORTED" (NO INFORMATION). A CONSUMER REPORTED TWO YEARS AGO HIS SON EXPERIENCED AN EYE INFECTION FOLLOWING THE USE OF THIS PRODUCT. HE STATED HIS SON WENT TO THE DOCTOR AND WAS TREATED WITH AN UNKNOWN MEDICATION. HE NOTED HIS SYMPTOMS DID RESOLVE. ON 08/30/2010, A TECH REPORTED THE PATIENT WAS SEEN IN THE OFFICE IN 2007, AND WAS DIAGNOSED WITH ALLERGIC CONJUNCTIVITIS AND CONTACT LENS OVERWEAR. SHE STATED THE OPTOMETRIST PRESCRIBED THE PATIENT ARTIFICIAL TEARS AND AN ANTIHISTAMINE. SHE REPORTED IT IS UNK IF THIS EVENT IS RELATED TO THE SOLUTION.

    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 18 YR Required Intervention ACUVUE OASYS SOFT CONTACT LENSES