BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTI-FREE REPLENISH

    MDR report key: 1961072 · Received January 12, 2011

    Report

    Report Number
    1610287-2010-00161
    Event Type
    Injury
    Date Received
    January 12, 2011
    Date of Event
    May 1, 2010
    Report Date
    December 13, 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
    NJ, 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 (B)(6) 2010; VIA FAX ON (B)(6) 2010, VIA PHONE ON (B)(6) 2010, (B)(6) 2010, (B)(6) 2011 AND (B)(6) 2011; AND VIA E-MAIL ON (B)(6) 2010. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED HE EXPERIENCED A CORNEAL INFECTION WHICH RESULTED IN A FIVE MONTH LONG PARTIAL LOSS OF VISION FOLLOWING THE USE OF THIS PRODUCT. HE STATED HE IS CURRENTLY SEEING A CORNEAL SPECIALIST WHO IS TREATING HIM WITH STEROID AND ANTIBIOTIC DROPS. ON (B)(6) 2010, ADDITIONAL INFO WAS RECEIVED FROM THE CONSUMER STATING HE ALSO EXPERIENCED IRRITATION, RED EYES, FELT AS IF HE HAD A FILM OVER HIS EYES, BLURRY VISION, SENSITIVITY TO LIGHT AND BUMPS UNDER HIS EYELIDS. HE REPORTED HIS DOCTOR PRESCRIBED HIM A CORTICOSTEROID AND AN ANTI-INFLAMMATORY CORTICOSTEROID FOUR TIMES A DAY. HE NOTED AT THIS TIME HE IS STILL NOT WEARING CONTACT LENSES AND HIS SYMPTOMS ARE NOT IMPROVING. HE REPORTED HE WILL BE FOLLOWING UP WITH THE CORNEAL SPECIALIST IN A COUPLE OF WEEKS. ON (B)(6) 2011, ADDITIONAL INFO WAS RECEIVED FROM THE CORNEAL SPECIALIST STATING HE DIAGNOSED THE CONSUMER WITH CORNEAL KERATITIS. HE STATED HE TREATED THE CONSUMER WITH AN ANTIBIOTIC/ANTIFUNGAL DROP, A CORTICOSTEROID AND ANTI-INFLAMMATORY CORTICOSTEROID DROP. HE NOTED THE CONSUMER IS STILL OUT OF HIS CONTACT LENSES. HE REPORTED THE PT'S SYMPTOMS HAVE RESOLVED AND IT IS UNLIKELY THE PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT. ADDITIONAL INFO HAS BEEN REQUESTED.

    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 25 YR Required Intervention PLUS| CRESTOR| ACUVUE OASYS SOFT CONTACT LENSES WITH HYDRACLEAR| INSULIN