BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION

    MDR report key: 2031622 · Received March 16, 2011

    Report

    Report Number
    1610287-2011-00027
    Event Type
    Injury
    Date Received
    March 16, 2011
    Report Date
    February 14, 2011
    Manufacturer
    ALCON-FORT WORTH/ALCON LABORATORIES, INC.
    Product Code
    LPN
    PMA / PMN Number
    K021143
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: NO LOT CODE OR SAMPLE WAS RETURNED BY THE CUSTOMER, THEREFORE, NO FURTHER EVAL CAN BE CONDUCTED AT THIS TIME. THE ROOT CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED. CITATION: KNAPE, R.M., MOTAMARRY, S.P., SAKHALKAR, M.V., TULI, S.S., AND DRIEBE, W.T. (2011). PSEUDODENDRITIC FUNGAL EPITHELIAL KERATITIS IN AN EXTENDED WEAR CONTACT LENS USER. EYE & CONTACT LENS, 36-38. (B)(4). THIS REPORT WAS MAILED TO FDA ON: 03/16/2011. (B)(4).

    Description of Event or Problem · 1

    IN A LITERATURE ARTICLE, "PSEUDODENDRITIC FUNGAL EPITHELIAL KERATITIS IN AN EXTENDED WEAR CONTACT LENS USER", PUBLISHED IN EYE AND CONTACT LENS IN 2011, AN OPHTHALMOLOGIST REPORTED A PT WHO WAS DIAGNOSED WITH PSEUDODENDRITIC FUNGAL EPITHELIAL KERATITIS FOLLOWING THE USE OF THIS PRODUCT. HE STATED THE PT PRESENTED WITH A 36-HOUR HISTORY OF LEFT EYE PAIN THAT WAS SHARP AND INTERMITTENT, AND ASSOCIATED WITH DECREASED VISION, PHOTOPHOBIA, AND TEARING. HE REPORTED THE PT STORED HER LENSES IN THIS PRODUCT OVERNIGHT; HOWEVER, SHE DID ADMIT TO OCCASIONALLY STORING HER LENSES IN TAP WATER AND RISING HER EYES WITH TAP WATER WHILE WEARING CONTACT LENSES. HE ALSO NOTED THE PT FREQUENTLY SLEPT IN HER CONTACT LENSES AND HAD DONE SO THE EVENING BEFORE HER PRESENTATION. HE REPORTED THE PT HAD VISITED ANOTHER OPHTHALMOLOGIST WHO HAD SUSPECTED AN EPITHELIAL HERPETIC KERATITIS AND HAD STARTED HER ON AN ANTIVIRAL DRUG. THE OPHTHALMOLOGIST REPORTED WHEN THE PT WAS SEEN IN THE OFFICE HER LEFT EYE BCVA WAS 20/30 WITH SIGNIFICANT CONJUNCTIVAL INJECTION. HE STATED HER LEFT NASAL PARACENTRAL CORNEAL EPITHELIUM HAD AN IRREGULAR SURFACE APPROX 3MM IN DIAMETER WITH A BRANCHING APPEARANCE. HE NOTED THE REMAINDER OF HER INITIAL VISITS EYE EXAMINATION WAS NORMAL. HE REPORTED THE PT WAS STARTED ON A REGIMEN OF AN ANTIFUNGAL MEDICATION AND ANTIFUNGAL ANTIBIOTIC ALTERNATING EVERY 30 MINUTES. IN ADDITION, SHE WAS PRESCRIBED ON ANTIBIOTICS FOUR TIMES A DAY. ON DAY 2, THE OPHTHALMOLOGIST REPORTED HER VISION HAD DECREASED SLIGHTLY AND A FEW FAINT STROMAL INFILTRATES UNDER THE SITE OF THE CORNEAL SCRAPING WERE PRESENT. ON DAY 3, HE STATED THE PT'S VISION HAD REACHED ITS NADIR AND THE ANTERIOR STROMAL INFILTRATES WERE SLIGHTLY DENSE WITH A MILD ACCOMPANYING ANTERIOR CHAMBER REACTION. HE REPORTED SHE WAS MAINTAINED ON THE AGGRESSIVE FORTIFIED ANTIFUNGAL REGIMEN FOR ONE WEEK, AT WHICH TIME, SHE BEGAN TO SHOW CLINICAL IMPROVEMENT WITH REGRESSION OF THE STROMAL INFILTRATES AND COMPLETE RESOLUTION OF THE EPITHELIOPATHY. HE NOTED THE ANTIBIOTICS WERE DISCONTINUED AND THE ANTIFUNGAL MEDICATIONS WERE DECREASED TO SIX TIMES A DAY FOR THE FOLLOWING WEEKS, THEN FOUR TIMES DAILY FOR ANOTHER WEEK BEFORE DISCONTINUATION. HE REPORTED THE STROMAL INFILTRATES REGRESSED TO BARELY VISIBLE SCARS, AND HER VISION RETURNED TO ITS BASELINE OF 20/25.

    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 48 YR Required Intervention NONSTEROIDAL ANTI-INFLAMMATORIES FOR LOWER| LENSES APPROXIMATELY TWO WEEKS OLD| ACUVUE OASYS EXTENDED WEAR SOFT CONTACT| BACK PAIN