BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTI-FREE REPLENISH

    MDR report key: 1243145 · Received November 21, 2008

    Report

    Report Number
    1610287-2008-00048
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    September 21, 2008
    Report Date
    October 24, 2008
    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
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE COMPLAINT DEVICE ASSOCIATED WITH THIS REPORT HAS NOT BEEN RECEIVED FOR EVALUATION. BATCH RECORDS WERE REVIEWED FOR LOT 151882F AND NO DEVIATIONS WERE IDENTIFIED. THE CHEMISTRY AND MICROBIOLOGY TEST RESULTS WERE REVIEWED AND FOUND TO BE ACCEPTABLE. THERE ARE NO SIMILAR REPORTS FOR LOT 151882F. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. STENOTROPHOMONAS MALTOPHILIA IS AN AEROBIC GRAM-NEGATIVE BACILLUS THAT IS FOUND IN VARIOUS AQUATIC ENVIRONMENTS. IT IS AN UNCOMMON PATHOGEN IN HUMANS AND USUALLY INCAPABLE OF CAUSING DISEASE IN HEALTHY HOSTS.

    Description of Event or Problem · 1

    AN ATTORNEY REPORTED A CONSUMER EXPERIENCED OCULAR IRRITATION, PAIN, REDNESS, LIGHT SENSITIVITY, TEMPORARY LOSS OF VISION AND DEPTH PERCEPTION WITH USE OF THIS PRODUCT. PER MEDICAL RECORDS PROVIDED BY THE ATTORNEY, THE CONSUMER VISITED A HOSPITAL EMERGENCY ROOM WHERE AN ATTENDING PHYSICIAN DIAGNOSED "CONJUNCTIVITIS" AND "IRITIS" IN 2008. HE TREATED HER WITH AN OPHTHALMIC ANTIBIOTIC AND AN ORAL PAIN MEDICATION. THE SAME DAY, THE PATIENT WAS EXAMINED BY AN OPTOMETRIST WHO DIAGNOSED "SUPERFICIAL PUNCTATE KERATITIS" (SPK). TWO DAYS LATER, AN OPHTHALMOLOGIST EXAMINED THE CONSUMER AND DIAGNOSED A "CENTRAL CORNEAL ULCER" IN HER RIGHT EYE AND A DIAGNOSTIC CORNEAL SCRAPE WAS PERFORMED AT THAT TIME. ACCORDING TO THE LAB RESULTS, THE CULTURE TESTED POSITIVE FOR "STENOTROPHOMONAS MALTOPHILIA." IN THE MEDICAL RECORDS, AN OPHTHALMOLOGIST REPORTED THE FOLLOWING MONTH THAT THE CONSUMER IS UNDERGOING TREATMENT FOR AN "EYE INFECTION" IN HER RIGHT EYE. HE INDICATED SHE HAS POOR VISION, LIGHT SENSITIVITY AND PAIN. SHE IS BEING TREATED WITH ANTIBIOTIC MEDICATIONS.

    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 151882F

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention LISINOPRIL 2.5 MG DAILY (ANTIHYPERTENSIVE)