BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTI-FREE REPLENISH

    MDR report key: 1782720 · Received July 28, 2010

    Report

    Report Number
    1610287-2010-00090
    Event Type
    Injury
    Date Received
    July 28, 2010
    Date of Event
    June 1, 2010
    Report Date
    June 28, 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
    ME, US
    Reporter Occupation
    NOT APPLICABLE

    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 MFG DOCUMENTATION. ADDITIONAL INFO REQUESTED VIA MAIL ON 06/29/2010 AND 07/19/2010; VIA FAX ON 07/19/2010; AND VIA PHONE ON 07/09/2010 AND 07/19/2010. MEDICAL RECORDS WERE RECEIVED ON 07/19/2010. ADDITIONAL INFO HAS BEEN REQUESTED FROM THE CONSUMER. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "INFECTION" (INFECTION); "ULCERS ON THE WHITE PART OF THE EYE" (ULCER); "INFLAMED CORNEA" (CORNEAL EDEMA); "REDNESS" (RED EYE(S)); "THROBBING PAIN AND STINGING" (PAIN); "KERATOCONJUNCTIVITIS" (CONJUNCTIVITIS); "GOOP" (DISCHARGE). PRODUCT PROBLEM(S): "NONE REPORTED" (NO INFO). A CONSUMER REPORTED SHE WENT TO HER DOCTOR BECAUSE SHE THOUGHT SHE WAS HAVING A REACTION TO HER LENSES. SHE STATED HER DOCTOR DIAGNOSED HER WITH A SEVERE INFECTION FOLLOWING THE USE OF THIS BOTTLE OF PRODUCT. ON (B)(6)2010, THE CONSUMER STATED SHE DISCONTINUED CONTACT LENS WEAR AND HER SYMPTOMS RESOLVED. SHE REPORTED SHE STARTED USING THE PRODUCT AGAIN AND HER SYMPTOMS RETURNED. SHE NOTED THE DOCTOR HAD ALSO DIAGNOSED HER WITH ULCERS ON THE WHITE PART OF HER EYE (SCLERA CONJUNCTIVA) AND AN INFLAMED CORNEA. SHE STATED THE DOCTOR TREATED HER WITH AN ANTIBIOTIC EYE DROP. SHE STATED SHE SWITCHED TO A HYDROGEN PEROXIDE BASED CONTACT LENS SOLUTION AND HER SYMPTOMS RESOLVED. ON 07/19/2010, THE CONSUMER'S OPTOMETRIST REPORTED THE CONSUMER WAS SEEN ON (B)(6)2010 WITH REDNESS AND STINGING IN BOTH EYES, A THROBBING PAIN IN THE RIGHT EYE, AND GOOP IN THE LEFT EYE. SHE STATED SHE DIAGNOSED THE PT WITH MARGINAL KERATOCONJUNCTIVITIS AND PRESCRIBED THE PT A COMBINATION ANTIBIOTIC STEROID FOUR TIMES A DAY FOR 5 DAYS. THE OPTOMETRIST REPORTED SHE SAW THE PT ON (B)(6)2010 AND SHE WAS DOING BETTER AND THE CORNEA WAS CLEAR.

    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 Required Intervention ACUVUE 2| AIR OPTIX CONTACT LENSES