BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTI-FREE REPLENISH

    MDR report key: 1963327 · Received January 14, 2011

    Report

    Report Number
    1610287-2010-00160
    Event Type
    Injury
    Date Received
    January 14, 2011
    Report Date
    December 15, 2010
    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
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT FOR THIS COMPLAINT IS IN ROUTE TO ALCON (B)(4) FROM ALCON (B)(4) FOR EVALUATION. THE COMPLAINT HISTORY WAS REVIEWED FOR THIS LOT AND THERE WERE NO OTHER COMPLAINTS OF THIS NATURE REPORTED. REVIEW OF THE COMPOUNDING AND FILLING MBRS 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. THE PRODUCT LITERATURE STATES TO STORE AT ROOM TEMPERATURE. THIS PRODUCT WAS SUBJECTED TO TEMPERATURES OUTSIDE THE SPECIFIED STORAGE CONDITIONS. THE ROOT CAUSE OF THIS INCIDENT IS DUE TO MISHANDLING OF THE PRODUCT BY IMPROPER STORAGE CONDITIONS. ADDITIONAL INFORMATION WAS REQUESTED ON (B)(6) 2010 AND (B)(6) 2010. ADDITIONAL INFORMATION WAS REC'D BY EMAIL ON (B)(6) 2011 AND BY PHONE ON (B)(6) 2011. A COMPLETED QUESTIONNAIRE WILL NOT BE RETURNED. (B)(4).

    Description of Event or Problem · 1

    AN OPTICIAN REPORTED A CONSUMER STATED THE PRODUCT WAS FROZEN AND AFTER THAWING, SHE USED IT WITH HER CONTACT LENSES. THE CONSUMER REPORTED THAT A MILKY VEIL WAS FORMED ON HER CONTACT LENSES AND SHE FELT THAT VISUAL ACUITY WAS IMPAIRED. ON (B)(6) 2011, THE OPTICIAN CONFIRMED THE PRODUCT HAD BEEN FROZEN AND WHEN THE CONSUMER USED IT, IT WAS MILKY, WHICH AFFECTED HER VISUAL ACUITY. ON (B)(6) 2011, THE OPTICIAN STATED THAT IT WAS HIS UNDERSTANDING THAT THE IMPAIRMENT OF THE VISUAL ACUITY WAS DUE TO THE FILM ON THE CONTACT LENSES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    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 JF92971GB

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other SOFT CONTACT LENSES - BRAND UNK