BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTI-FREE REPLENISH

    MDR report key: 2031636 · Received March 16, 2011

    Report

    Report Number
    1610287-2011-00023
    Event Type
    Injury
    Date Received
    March 16, 2011
    Date of Event
    November 29, 2010
    Report Date
    February 14, 2011
    Manufacturer
    ALCON - FORT WORTH/ALCON LABORTORIES, INC.
    Product Code
    LPN
    PMA / PMN Number
    K050729
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: NO SAMPLE WAS RETURNED BY THE CUSTOMER. THE COMPLAINT HISTORY WAS REVIEWED FOR THIS LOT AND THERE WAS ONE COMPLAINT REPORTED FOR EYE IRRITATION. REVIEW OF THE COMPOUNDING AND FILLING MBR'S 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. ADDITIONAL INFO WAS REQUESTED VIA MAIL ON 02/15/2011; VIA FAX ON 02/15/2011; VIA PHONE ON 02/21/2011. (B)(4).

    Description of Event or Problem · 1

    AN OPHTHALMOLOGIST INITIALLY REPORTED A PT WHO EXPERIENCED SEVERE KERATITIS FOLLOWING THE USE OF THIS PRODUCT. SHE STATED SHE TREATED THE EVENT WITH AGGRESSIVE LUBRICATION. ON (B)(6) 2011, ADDITIONAL INFO WAS RECEIVED FROM THE OPHTHALMOLOGIST STATING THIS PT WAS DIAGNOSED WITH MODERATE TO SEVERE PUNCTATE KERATITIS THAT IS NOT ASSOCIATED WITH CONTACT LENS OVERWEAR OR FIT PROBLEMS. SHE STATED SHE DISCONTINUED CONTACT LENS WEAR AND SWITCHED THE PT TO A HYDROGEN PEROXIDE BASED CONTACT LENS SOLUTION. SHE NOTED SHE TREATED THE PT WITH A PRESERVATIVE FREE ARTIFICIAL TEAR AND OINTMENT. SHE REPORTED AT THIS TIME, THE PT'S SYMPTOMS WERE RESOLVING. THIS REPORT IS FOR PT 1 OF 7.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTI-FREE REPLENISH LENS CARE DISINFECTING SOLUTIONS LPN ALCON - FORT WORTH/ALCON LABORTORIES, INC. NA 178872F

    Patients

    Seq Age Sex Outcome Treatment
    1 Other PRESERVATIVE FREE REWETTING DROP| ACUVUE OASYS SOFT CONTACT LENSES