BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTIONS

    MDR report key: 1910366 · Received November 18, 2010

    Report

    Report Number
    1610287-2010-00137
    Event Type
    Injury
    Date Received
    November 18, 2010
    Report Date
    October 19, 2010
    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
    IS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE COMPLAINT DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RECEIVED FOR EVALUATION. IT IS UNK IF THE PRODUCT WAS USED ACCORDING TO LABELED INDICATIONS. NO OTHER COMPLAINTS OF THIS NATURE HAVE BEEN REPORTED FOR THIS LOT. REVIEW OF THE MANUFACTURING BATCH RECORDS 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. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED EXPERIENCING EYE INFECTIONS, REDNESS AND PAIN WITH USE OF THIS PRODUCT. SHE STATED, SHE HAD USED THE PRODUCT IN THE PAST AND DISCONTINUED USE. WHEN SHE USED THE PRODUCT AGAIN, THESE EVENTS OCCURRED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTIONS LENS CARE DISINFECTING SOLUTIONS LPN ALCON - FORT WORTH/ ALCON LABORATORIES. INC. NA 177826F

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other