BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTI-FREE REPLENISH

    MDR report key: 1648176 · Received March 31, 2010

    Report

    Report Number
    1610287-2010-00030
    Event Type
    Injury
    Date Received
    March 31, 2010
    Date of Event
    October 20, 2009
    Report Date
    March 1, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE COMPLAINT DEVICE WAS NOT RECEIVED 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 HAS BEEN REQUESTED VIA PHONE ON 03/01/2010, 03/16/2010, AND 03/22/2010; VIA MAIL ON 03/02/2010; VIA FAX ON 03/02/2010. ADDITIONAL INFORMATION WAS RECEIVED FROM THE OPTOMETRIST ON 03/22/2010. (B) (4)

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "TOXIC CENTRAL KERATITIS" (KERATITIS), "RED EYES" (RED EYE(S)), "PHOTOPHOBIA" (NO CODE AVAILABLE), "SORE EYES" (PAIN), "DECREASED VISION" (VISION, IMPAIRED), "SUPERIOR PANNUS" (NEOVASCULARIZATION), PRODUCT PROBLEM(S): "NONE REPORTED" (NO INFORMATION). ON 03/01/2010, AN OPTOMETRIST REPORTED, SHE DIAGNOSED A PATIENT WITH TOXIC CENTRAL KERATITIS AND SUPERIOR PANNUS FOLLOWING THE USE OF THIS PRODUCT WITH HYBRID HYDROGEL CONTACT LENSES. SHE STATED THE PATIENT EXPERIENCED FREQUENT RED, SORE EYES, POOR TOLERANCE TO LENSES, PHOTOPHOBIA, AND DECREASED VISION. SHE REPORTED SHE PRESCRIBED THE PATIENT AN ANTIBIOTIC AND PRESERVATIVE FREE ARTIFICIAL TEARS. THE OPTOMETRIST INDICATED THE CONSUMER DISCONTINUED CONTACT LENS WEAR FROM (B) (6) 2009-(B) (6) 2009. SHE ALSO INDICATED SHE SWITCHED THE PATIENT TO SALINE FOR SENSITIVE EYES SOLUTION AND DAILY DISPOSABLE CONTACT LENSES. ON 03/22/2010, THE OPTOMETRIST REPORTED THE PATIENT'S VISION DECREASED, BUT IS NOW BCVA 2020. SHE STATED THE PATIENT'S SYMPTOMS HAVE RESOLVED.

    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 25 YR Required Intervention ACUVUE OASYS CONTACT LENSES (DATES UNKNOWN)