BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE OASYS BRAND CONTACT LENSES

    MDR report key: 3735689 · Received April 1, 2014

    Report

    Report Number
    1033553-2014-00034
    Event Type
    Injury
    Date Received
    April 1, 2014
    Report Date
    April 1, 2014
    Manufacturer
    LIMERICK IRELAND
    Product Code
    LPL
    PMA / PMN Number
    P040045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS REQUESTED BUT HAS NOT BEEN RECEIVED. A DEVICE HISTORY REVIEW WAS PERFORMED. THE BATCH RECORD DID NOT SHOW ANY ABNORMALITIES IN MONOMER AND SOLUTION TESTING. ALL PARAMETERS TESTED WERE WITHIN SPECIFICATION. ALL STERILIZATION REQUIREMENTS WERE SUCCESSFULLY COMPLETED. IF ADDITIONAL INFORMATION IS RECEIVED, WILL REPORT WITHIN 30 DAYS OF RECEIPT. MDR REPORTABLE EVENT TRENDS ARE REVIEWED IN QUARTERLY MANAGEMENT REVIEW MEETINGS. DEVICE LABELING FOR SINGLE USE OR REUSE. DEVICE NOT RETURNED, NO EVALUATION WILL BE PROVIDED; UNABLE TO CONFIRM COMPLAINT.

    Description of Event or Problem · 1

    ON (B)(6) 2014, OUR (B)(4) AFFILIATE RECEIVED AN E-MAIL FROM A PATIENT REPORTING HAVING EXPERIENCED AN OCULAR EVENT WHILE WEARING ACUVUE OASYS CONTACTS LENSES (CL). THE PATIENT WAS WEARING THE LENSES ON A DAILY WEAR SCHEDULE, AND USING OPTI-FREE LENS CARE SOLUTION. THE PATIENT HAD WORN CONTACT LENSES FOR OVER 10 YEARS INCLUDING ACUVUE PRODUCT. SHE RECENTLY STARTED WEARING ACUVUE OASYS LENSES AND REPORTED REDNESS OS AND "ON THE SECOND DAY OF USE MY LEFT EYE BECAME IRRITATED AND I WENT TO AN OPHTHALMOLOGIC URGENT THAT DETECTED THE BEGINNING OF AN ULCER CAUSED BY THE LENS." THE TREATMENT REGIMEN INCLUDED FLUTINOL Q6 HRS X 14 DAYS, OFLOXACIN Q6 HRS X 4 DAYS, AND HYLO-COMOD QHR. THE PATIENT HAD RESUMED CONTACT LENS WEAR. DUE TO THE LIMITED INFORMATION PROVIDED THE EVENT IS CLASSIFIED AS A CORNEAL ULCER. OUR FIRM WAS UNABLE TO CONFIRM THE DIAGNOSIS OR TREATMENT WITH THE TREATING EYE CARE PROFESSIONAL. CORNEAL ULCER MAY OR MAY BE A SERIOUS INJURY, DUE TO THE LIMITED AMOUNT OF INFORMATION THE EVENT IS SUBMITTED AS WORST CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195248 ACUVUE OASYS BRAND CONTACT LENSES DISPOSABLE SOFT CONTACT LENS LPL LIMERICK IRELAND NA L0022ND

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other| R OPTI FREE LENS CARE SOLUTION