BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION

    MDR report key: 2063753 · Received April 14, 2011

    Report

    Report Number
    1610287-2011-00041
    Event Type
    Injury
    Date Received
    April 14, 2011
    Date of Event
    October 1, 2010
    Report Date
    February 23, 2011
    Manufacturer
    ALCON - FORT WORTH / ALCON LABORATORIES, INC.
    Product Code
    LPN
    PMA / PMN Number
    K021143
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: NO LOT CODE WAS PROVIDED AND NO SAMPLE WAS RETURNED; THEREFORE, NO FURTHER EVALUATION COULD BE PERFORMED AT THIS TIME. NO ROOT CAUSE COULD BE DETERMINED. ADDITIONAL INFORMATION WAS REQUESTED VIA PHONE ON 03/23/2011, 03/15/2011, AND 04/12/2011; VIA MAIL ON 02/23/2011 AND 03/15/2011. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER INITIALLY REPORTED SHE EXPERIENCED SEVERE DRY EYE AND SEVERELY IRRITATED CORNEAS FOLLOWING THE USE OF THIS PRODUCT. ON (B)(6) 2011, ADDITIONAL INFORMATION WAS RECEIVED FROM THE CONSUMER WHO STATED IN (B)(6) 2010, SHE STARTED EXPERIENCING EXTREME DRY EYE, IRRITATION, AND RED EYES. SHE NOTED, SHE WENT TO HER OPTOMETRIST WHO DIAGNOSED HER WITH A PRESERVATIVE ALLERGY, SEVERE DRY EYES, A LESION TO THE SCLERA AND REFERRED HER TO AN OPHTHALMOLOGIST. SHE REPORTED SHE DISCONTINUED CONTACT LENS WEAR AND THE OPHTHALMOLOGIST PRESCRIBED HER A STEROID DROP. SHE STATED HER EYES IMPROVED AND WHEN SHE WENT BACK TO CONTACT LENS USE, SHE STARTED EXPERIENCING THE SAME SYMPTOMS. SHE REPORTED, SHE RETURNED TO THE DOCTOR AND SHE WAS PRESCRIBED ANOTHER STEROID AND HER DOCTOR TOLD HER THAT HER CORNEAS WERE SEVERELY IRRITATED AND HER EYES WERE EXTREMELY DRY. ON (B)(6) 2011, ADDITIONAL INFORMATION WAS RECEIVED FROM THE CONSUMER STATING HER SYMPTOMS ARE RESOLVING. THIS IS THE FIRST OF TWO REPORTS FOR THIS PATIENT.

    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 LABORATORIES, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other ACUVUE SOFT CONTACT LENSES