BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTI-FREE REPLENISH

    MDR report key: 1822525 · Received August 27, 2010

    Report

    Report Number
    1610287-2010-00107
    Event Type
    Injury
    Date Received
    August 27, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 29, 2010
    Manufacturer
    ALCON - FORT WORTH / ALCON LABORATIES, INC.
    Product Code
    LPN
    PMA / PMN Number
    K050729
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE COMPLAINT DEVICE WAS NOT REC'D FOR EVALUATION. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. ADDITIONAL INFORMATION WAS REQUESTED BY MAIL ON 07/29/2010 AND 08/23/2010 AND BY PHONE ON 08/18/2010 AND 08/23/2010. A COMPLETED QUESTIONNAIRE HAS NOT BEEN REC'D. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "RED" (RED EYE(S)); "IRRITATION" (IRRITATION); "INFECTION" (INFECTION). PRODUCT PROBLEM(S): "NONE REPORTED" (NO INFORMATION). A CONSUMER REPORTED THAT SHE EXPERIENCED AN INFECTION FOLLOWING USE OF THIS BOTTLE PRODUCT. SHE EXPLAINED THAT HER EYES DID NOT FEEL UNCOMFORTABLE WHILE WEARING HER LENSES, BUT AFTER SHE REMOVED THEM, HER EYES BECAME VERY RED AND IRRITATED. SHE SPOKE WITH HER DOCTOR AND EXPLAINED HER SYMPTOMS AND HE TREATED HER FOR PINK EYE. SHE WAS PRESCRIBED OPHTHALMIC ANTIBACTERIAL EYE DROPS FOR ONE WEEK AND DISCONTINUED CONTACT LENS WEAR. SHE STATED THAT AFTER FIVE DAYS, SHE STARTED WITH A NEW PAIR OF CONTACT LENSES BUT USED THE SAME BOTTLE OF SOLUTION AND EXPERIENCED THOSE SAME SYMPTOMS. SHE WILL F/U WITH HER DOCTOR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention