BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTI-FREE MULTI-ACTION SOLUTION

    MDR report key: 2210335 · Received August 9, 2011

    Report

    Report Number
    1610287-2011-00074
    Event Type
    Injury
    Date Received
    August 9, 2011
    Date of Event
    June 29, 2010
    Report Date
    July 10, 2011
    Manufacturer
    ALCON - FORT WORTH / ALCON LABORATORIES, INC.
    Product Code
    LPN
    PMA / PMN Number
    P830034
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR EVALUATION. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. THIS PRODUCT IS ENROLLED IN THE STABILITY PROGRAM IN WHICH IT IS TESTED ACCORDING TO THIS PRODUCT'S STABILITY SPECIFICATIONS ON A SET SCHEDULE. A REVIEW OF THE STABILITY DATA FOR ALL (B)(4) LOTS OF THIS PRODUCT CURRENTLY ENROLLED IN THE STABILITY PROGRAM WAS CONDUCTED AND ALL LOTS REMAIN WITHIN SPECIFICATION THROUGH PRODUCT EXPIRATION. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A HEALTHCARE PROFESSIONAL INITIALLY REPORTED A PATIENT HAD A CORNEAL INFECTION WITH USE OF THIS PRODUCT. ON (B)(6) 2011, ADDITIONAL INFORMATION WAS RECEIVED FROM THE PHYSICIAN STATING THAT THE PATIENT VISITED THE CLINIC ON (B)(6) 2010 AND COMPLAINED OF OCULAR HYPERAEMIA, EYE PAIN AND LACRIMATION IN BOTH EYES (OU). THE PHYSICIAN STATED THAT CORNEAL INFILTRATES WERE OBSERVED OU. HE TREATED THE PATIENT WITH ANTIBIOTIC MEDICATIONS AND THE SYMPTOMS RESOLVED ON (B)(6) 2010. THE PATIENT WAS PRESCRIBED TWO-WEEK DISPOSABLE SOFT CONTACT LENSES AND THE SOLUTION WAS SWITCHED TO POVIDONE-IODINE. THE PHYSICIAN REPORTED THAT STENOTROPHOMONAS MALTOPHILIA WAS DETECTED IN THE LENS CONTAINER AND THE BOTTLE OF PRODUCT BY CULTIVATION TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTI-FREE MULTI-ACTION SOLUTION LENS CARE DISINFECTING SOLUTIONS LPN ALCON - FORT WORTH / ALCON LABORATORIES, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Other ACUVUE OASYS