BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION

    MDR report key: 1243143 · Received November 21, 2008

    Report

    Report Number
    1610287-2008-00044
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    October 8, 2008
    Report Date
    October 29, 2008
    Manufacturer
    ALCON- FORT WORTH/ALCON LABORTAORIES, INC.
    Product Code
    LPN
    PMA / PMN Number
    K021143
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTER PROVIDED AN UNMARKED CLEAR BOTTLE CONTAINING A SOLUTION AND HAS BEEN ASKED TO RETURN THE ORIGINAL BOTTLE OF PRODUCT. PRODUCT HISTORY RECORDS COULD BE NOT REVIEWED BECAUSE THE REPORTER HAS NOT PROVIDED AN ACCURATE LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. THIS REPORT WAS MAILED TO FDA ON: 11/21/2008.

    Description of Event or Problem · 1

    A CONSUMER REPORTED EXPERIENCING OCULAR REDNESS, IRRITATION, PAIN, TEARING AND BLURRED VISION IN HER RIGHT EYE (OD) AFTER USING THIS PRODUCT. SHE FURTHER STATED THAT HER VISION WAS SIGNIFICANTLY INHIBITED DUE TO LIGHT SENSITIVITY. SHE INDICATED SHE VISITED A HOSPITAL EMERGENCY ROOM ON THE NIGHT OF THE EVENT DATE WHERE A DOCTOR DIAGNOSED "CORNEAL ULCERATIONS" (OD) UPON EXAMINATION AND REFERRED HER TO A SPECIALIST EYE CLINIC. THE NEXT DAY ACCORDING TO THE CONSUMER, SHE WAS DIAGNOSED WITH "FUNGAL KERATITIS" FOLLOWING LABORATORY TESTING. THE CONSUMER IS BEING TREATED WITH ANTI-FUNGAL MEDICATION. IN THE SAME MONTH, THE CONSUMER VISITED THE EYE SPECIALIST AND THERE IS A SUSPECTED CORNEAL ULCERATION IN THE LEFT EYE (OS) ALTHOUGH IT WAS NOT CONCLUSIVELY DIAGNOSED AT THAT TIME. THE CONSUMER PURCHASED THE BOTTLE OF PRODUCT WHILE TRAVELING IN BARBADOS. THE FOLLOWING MONTH, THE CONSUMER REPORTED THAT TREATMENT IS CONTINUING AND THAT SHE HAD NOT WORN HER CONTACT LENSES SINCE THE SYMPTOMS INITIATED.

    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 LABORTAORIES, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention ACUVUE ADVANCE WITH HYDRACLEAR CONTACT LENSES