BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION

    MDR report key: 2000358 · Received February 18, 2011

    Report

    Report Number
    1610287-2011-00011
    Event Type
    Injury
    Date Received
    February 18, 2011
    Report Date
    January 20, 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
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE SAMPLE WAS RETURNED BY THE CUSTOMER. A VISUAL EXAMINATION OF THE EXTERIOR OF THE RETURNED SAMPLE SHOWED NO ANOMALIES WITH THE BOTTLE OR CAP THAT WOULD HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE CAP WAS REMOVED TO OBSERVE THE SOLUTION, THE SOLUTION APPEARED TO HAVE NO VISIBLE PARTICULATES, AND HAD TYPICAL ODOR, COLORING AND CLARITY. THIS PRODUCT LOT EXPIRED ON 12/31/2007. THE COMPLAINT HISTORY WAS REVIEWED FOR THIS LOT AND THERE WERE NO OTHER COMPLAINTS REPORTED. REVIEW OF THE COMPOUNDING AND FILLING MBR'S SHOWED NO 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 HOWEVER THIS CONDITION LIKELY OCCURRED DUE TO CUSTOMER USING THE PRODUCT LONG AFTER THE EXPIRATION DATE. ADDITIONAL INFORMATION WAS REQUESTED VIA MAIL ON 01/21/2011 AND 02/10/2011; VIA PHONE ON 02/01/2011 AND 02/16/2011. AT THIS TIME, ADDITIONAL INFORMATION HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED SHE EXPERIENCED A CORNEAL BURN FOLLOWING THE USE OF THIS PRODUCT. SHE STATED HER HEALTH CARE PROFESSIONAL NOTED IT WAS DUE TO THE SOLUTION; HOWEVER, WHEN THE PRODUCT WAS RETURNED IT WAS FOUND TO BE EXPIRED IN 2007. ADDITIONAL INFORMATION 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 73215F

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other