BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFLENS DAILY DISPOSABLE CONTACT LENS

    MDR report key: 6080562 · Received November 4, 2016

    Report

    Report Number
    0001313525-2016-00518
    Event Type
    Injury
    Date Received
    November 4, 2016
    Date of Event
    October 4, 2016
    Report Date
    October 3, 2016
    Manufacturer
    BAUSCH & LOMB INCORPORATED
    Product Code
    MVN
    PMA / PMN Number
    K061157
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT SAMPLE WAS RETURNED AND THE RESULTS OF THAT EVALUATION REVEALED A V-SHAPED NICK ON THE EDGE OF THE LENS. MEDICAL INFORMATION IS NOT AVAILABLE. THE DEVICE HISTORY RECORDS ARE BEING REVIEWED.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE LOT DEVICE HISTORY RECORDS CONCLUDES THAT THE PRODUCT WAS MANUFACTURED, PACKAGED AND RELEASED ACCORDING TO GLOBAL AND PLANT PRODUCT SPECIFICATIONS.

    Description of Event or Problem · 1

    CONSUMER REPORTED PAIN IN RIGHT EYE UPON INITIAL USE OF PRODUCT. CONSUMER VISITED EYE CLINIC AND STATED THAT DOCTOR NOTED SCRATCHES ON THE SCLERA OF RIGHT EYE. DOCTOR PRESCRIBED FLUMETHOLON OPHTHALMIC SUSPENTION AND TOSUFLO OPHTHALMIC SOLUTION. CONSUMER IS RECOVERED. MEDICAL DOCUMENTATION IS NOT AVAILABLE AS CONSUMER IS UNWILLING TO PROVIDE DOCTOR INFORMATION OR SIGN A MEDICAL RELEASE FORM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731044 SOFLENS DAILY DISPOSABLE CONTACT LENS LENS, CONTACT, DISPOSABLE MVN BAUSCH & LOMB INCORPORATED W62029263

    Patients

    Seq Age Sex Outcome Treatment
    1 Other