BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION

    MDR report key: 1924726 · Received December 9, 2010

    Report

    Report Number
    1610287-2010-00149
    Event Type
    Injury
    Date Received
    December 9, 2010
    Date of Event
    October 28, 2010
    Report Date
    November 9, 2010
    Manufacturer
    ALCON - FORT WORTH / ALCON LABS INC
    Product Code
    LPN
    PMA / PMN Number
    K021143
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE COMPLAINT DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED. IT IS UNK IF THE PRODUCT WAS USED ACCORDING TO LABELED INDICATIONS. BATCH RECORDS WERE REVIEWED FOR LOT 178722F AND NO DEVIATIONS WERE IDENTIFIED. VISUAL EXAM OF THE RETURNED SAMPLE SHOWED HAIR-LIKE DEBRIS ON THE CAP AND SHOULDER OF THE BOTTLE. CHEMISTRY AND MICROBIAL RESULTS, ENVIRONMENTAL, UTILITY, BIOBURDEN, AND SANITIZATION RECORDS WERE ALSO REVIEWED AND FOUND TO BE ACCEPTABLE. LOT 178722F MET ALL RELEASE CRITERIA PRIOR TO PRODUCT RELEASE. THERE ARE NO SIMILAR REPORTS FOR THIS LOT. ADDITIONAL INFO WAS REQUESTED VIA PHONE ON 11/10/2010; VIA MAIL ON 11/10/2010. ADDITIONAL INFO WAS RECEIVED FROM THE CONSUMER ON 11/22/2010. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED, SHE INITIALLY EXPERIENCED IRRITATION AND BURNING WHICH THE DOCTOR DIAGNOSED AS AN INFECTION FOLLOWING THE USE OF THIS PRODUCT. SHE STATED, SHE WAS TREATED WITH CORTICOSTEROID AND ANOTHER MEDICATION. ON (B)(6) 2010, THE CONSUMER STATED, SHE HAD CONJUNCTIVITIS WHICH SHE DOES NOT FEEL IS RELATED TO THE PRODUCT. SHE REPORTED, THE CONJUNCTIVITIS IS NOW CLEARED BUT SHE HAS LINGERING REDNESS AND BURNING. SHE NOTED, SHE HAS NOT WORN HER LENSES SINCE SHE HAD THE INFECTION. ON 11/22/2010, THE CONSUMER REPORTED SEVERE REDNESS IN BOTH EYES FROM (B)(6) 2010 TO THE PRESENT. SHE STATED, HER DOCTOR TREATED HER WITH LUBRICANT EYE DROPS AND A CORTICOSTEROID. SHE NOTED, HER SYMPTOMS ARE RESOLVING AND SHE DID NOT GIVE PERMISSION TO CONTACT HER DOCTOR.

    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 LABS INC NA 178722F

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other SOFT CONTACT LENSES (BRAND AND DATES UNK)