BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTI-FREE REPLENISH

    MDR report key: 2192450 · Received July 27, 2011

    Report

    Report Number
    1610287-2011-00070
    Event Type
    Injury
    Date Received
    July 27, 2011
    Date of Event
    June 10, 2011
    Report Date
    June 27, 2011
    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
    PA, 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 BY FAX AND MAIL ON 06/28/2011 AND 07/22/2011 AND BY PHONE ON 07/14/2011 AND 07/22/2011. A COMPLETED QUESTIONNAIRE WAS RECEIVED FROM THE OPTOMETRIST ON 06/28/2011. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT SHE EXPERIENCED A BAD REACTION AND WAS DIAGNOSED WITH A VIRAL INFECTION AND RED, IRRITATED EYES FOLLOWING USE OF THIS PRODUCT. SHE WAS TREATED WITH ANTIBIOTIC STEROID DROPS AND HER EYES ARE IMPROVING. A QUESTIONNAIRE WAS RECEIVED FROM THE OPTOMETRIST ON (B)(6) 2011. THE OPTOMETRIST REPORTED HIS PT EXPERIENCED RED, IRRITATED EYES AND A YELLOW DISCHARGE WHICH CAUSED HER EYELIDS TO STICK TOGETHER. HE DIAGNOSED HIS PT WITH BACTERIAL CONJUNCTIVES IN BOTH EYES AND PRESCRIBED ANTIBIOTIC/STEROID DROPS FOR TREATMENT. THE OPTOMETRIST STATED THE EVENT IS RESOLVING AND IS UNLIKELY RELATED TO THE PRODUCT.

    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 55 YR Other B&L PURE VISION MULTIFOCAL CONTACT LENSES