BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION

    MDR report key: 2065313 · Received April 13, 2011

    Report

    Report Number
    1610287-2011-00035
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    February 1, 2011
    Report Date
    March 14, 2011
    Manufacturer
    ALCON - FORT WORTH / ALCON LABORATORIES, INC.
    Product Code
    LPN
    PMA / PMN Number
    K021143
    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: NO SAMPLE WAS RETURNED BY THE CUSTOMER. THE COMPLAINT HISTORY WAS REVIEWED FOR THIS LOT AND THERE WERE NO OTHER COMPLAINTS OF THIS NATURE REPORTED. REVIEW OF THE COMPOUNDING AND FILLING (B)(4) DID NOT SHOW ANY ANOMALIES THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE CHEMISTRY AND MICROBIAL FINISHED PRODUCT RESULTS WERE REVIEWED AND FOUND TO BE ACCEPTABLE. THE ENVIRONMENTAL, UTILITY, BIOBURDEN, AND SANITIZATION RECORDS WERE REVIEWED AND FOUND TO BE ACCEPTABLE. THIS LOT MET ALL RELEASE CRITERIA PRIOR TO PRODUCT RELEASE. NO ROOT CAUSE CAN BE DETERMINED AT THIS TIME. ADD'L INFO HAS BEEN REQUESTED VIA MAIL ON 03/24/2011, 04/08/2011, AND 04/11/2011; VIA FAX ON 04/08/2011; VIA PHONE ON 04/08/2011. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED SHE EXPERIENCED RED, UNCOMFORTABLE EYES THAT GRADUALLY WORSENED OVER TIME FOLLOWING THE USE OF THIS PRODUCT. SHE STATED SHE WENT TO THE DOCTOR AND WAS DIAGNOSED WITH AN INFECTION AND TREATED WITH AN ANTIBIOTIC. SHE STATED SHE DISCONTINUED CONTACT LENS USE FOR TWO WEEKS AND WHEN SHE RETURNED TO HER LENSES SHE EXPERIENCED THE SAME SYMPTOMS. SHE REPORTED HER SYMPTOMS HAVE RESOLVED. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION LENS CARE DISINFECTING SOLUTIONS LPN ALCON - FORT WORTH / ALCON LABORATORIES, INC. NA 181301F

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other