BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTI-FREE REPLENISH

    MDR report key: 1180473 · Received September 26, 2008

    Report

    Report Number
    1610287-2008-00039
    Event Type
    Injury
    Date Received
    September 26, 2008
    Date of Event
    August 26, 2008
    Report Date
    August 28, 2008
    Manufacturer
    ALCON - FORT WORTH/ALCON LABORATORIES, INC.
    Product Code
    LPN
    PMA / PMN Number
    K050729
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE COMPLAINT DEVICE ASSOCIATED WITH THIS REPORT HAS BEEN RECEIVED FOR EVAL. BATCH RECORDS WERE REVIEWED FOR LOT 138838F AND NO DEVIATIONS WERE IDENTIFIED. THE CHEMISTRY AND MICROBIOLOGY TEST RESULTS WERE REVIEWED AND FOUND TO BE ACCEPTABLE. NO SIMILAR REPORTS FOR LOT 138838F. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFO BECOMES AVAILABLE. ADD'L INFO WAS REQUESTED ON 08/28/2008, 08/29/2008 (2), 09/03/2008 (2), 09/09/2008, 09/11/2008, AND 09/12/2008 BY FAX, MAIL, AND PHONE. ADDITIONAL INFO WAS RECEIVED ON 09/15/2008 BY FAX.

    Description of Event or Problem · 1

    AN OPTOMETRIST REPORTS THAT A NEW CONTACT LENS WEARER WORE HER LENSES FOR ONE DAY AND REPORTED OCULAR PAIN AND TROUBLE SEEING. THE LENS CASE AND TWO OUNCE BOTTLE OF LENS CARE SOLUTION THAT HAD BEEN USED BY THE PT WAS REPORTED TO HAVE SMELLED LIKE BLEACH. THE OPTOMETRIST DESCRIBED THIS AS AN ABRASION OR CHEMICAL BURN WITH THE UPPER LAYERS OF THE CORNEA REMOVED. SHE ALSO OBSERVED MICROCYSTIC EDEMA. FOLLOWING THE ONSET OF THE EVENT, THE OPTOMETRIST SAW THE PT DAILY AND TREATED HER WITH SEVERAL MEDICATIONS AND THERAPIES. TEN DAYS AFTER THE ONSET OF THE EVENT, MINIMAL STAINING WAS OBSERVED AND HER VISION WAS WORSE THAN 20/400. THE OPTOMETRIST FEELS THAT AS THE CORNEA HEALS, THE PT'S VISION WILL RETURN TO NORMAL. BECAUSE THE CORNEA IS HEALING, THE OPTOMETRIST DID NOT FEEL IT WAS NECESSARY TO SEND THE PT TO A CORNEAL SPECIALIST.

    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 138838F

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention