BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTI-FREE REPLENISH

    MDR report key: 1439628 · Received August 13, 2009

    Report

    Report Number
    1610287-2009-00027
    Event Type
    Injury
    Date Received
    August 13, 2009
    Date of Event
    May 30, 2009
    Report Date
    June 25, 2009
    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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE COMPLAINT DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED AND EVALUATED. PHYSICAL AND CHEMICAL PARAMETERS CONFORMED TO RELEASE SPECIFICATIONS. BATCH RECORDS WERE REVIEWED AND NO DEVIATIONS WERE IDENTIFIED. NO SIMILAR REPORTS FOR LOT 143079F. ADDITIONAL INFORMATION WAS REQUESTED ON 06/26/2009, 07/14/2009, 07/16/2006, 07/28/2009 AND 08/04/2009. ADDITIONAL INFORMATION WAS RECEIVED ON 07/14/2009, 07/16/2009 AND 07/28/2009.

    Description of Event or Problem · 1

    AN OPHTHALMOLOGIST REPORTED A PATIENT WHO IS EXPERIENCING LIMBAL STEM CELL DEFICIENCY, CORNEAL AND SUBEPITHELIAL HAZE, EPITHELIAL DEFICIENCY AND BLURRED VISION FOLLOWING USE OF THIS PRODUCT. THE EVENT WAS TREATED WITH PUNCTAL PLUGS AND TEARS MEDICATION. THE OPHTHALMOLOGIST STATED THAT THE PUNCTAL PLUG TREATMENT HELPED IMPROVE THE LEFT EYE, WHICH HAS RETURNED TO NORMAL, BUT THE RIGHT EYE HAS NOT IMPROVED. IN AN ADDITIONAL STATEMENT ON 07/28/2009, THE DOCTOR REPORTED THAT THE PATIENT'S SYMPTOMS WERE CONTINUING BUT WERE STARTING TO IMPROVE. THE DOCTOR COULD NOT RULE OUT THE POSSIBILITY THAT THE PRODUCT IS RELATED TO THE EVENT.

    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 143079F

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention ACUVUE OASYS CONTACT LENSES| B&L REWETTING DROPS - BID