BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFLENS 38 (POLYMACON) CONTACT LENS

    MDR report key: 6103355 · Received November 15, 2016

    Report

    Report Number
    0001313525-2016-00571
    Event Type
    Injury
    Date Received
    November 15, 2016
    Date of Event
    October 16, 2016
    Report Date
    October 17, 2016
    Manufacturer
    BAUSCH & LOMB INCORPORATED
    Product Code
    LPM
    PMA / PMN Number
    N16895
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CONSUMER REPORTED FEELINGS OF DISCOMFORT IN BOTH EYES WHILE USING PRODUCT. CONSUMER WAS PRESCRIBED CRAVIT OPHTHALMIC SOLUTION BUT WAS NOT DIAGNOSED. MEDICAL DOCUMENTATION FROM THE DOCTOR WAS NOT PROVIDED. CONSUMER IS RECOVERED. COMPLAINT SAMPLE WAS RETURNED AND EVALUATED. RESULT OF EVALUATION SHOWED A PUNCTURE HOLE IN THE CENTER OF THE LENS. A REVIEW OF THE LOT DEVICE HISTORY RECORDS IS IN PROGRESS.

    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 A FEELING OF DISCOMFORT UPON INITIAL USE OF PRODUCT. CONSUMER WORE SAME LENS IN ALTERNATE EYE ON FOLLOWING DAY. ONCE AGAIN, CONSUMER EXPERIENCED DISCOMFORT. CONSUMER VISITED AN EYE CLINIC FOR REPORTED DISCOMFORT IN BOTH EYES AND STATED THAT THE DOCTOR DID NOT PROVIDE ANY DIAGNOSIS BUT DID PRESCRIBE CRAVIT OPHTHALMIC SOLUTION. CONSUMER IS RECOVERED. MEDICAL DOCUMENTATION FROM THE DOCTOR WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753029 SOFLENS 38 (POLYMACON) CONTACT LENS LENSES, SOFT CONTACT, EXTENDED WEAR LPM BAUSCH & LOMB INCORPORATED Y51905310

    Patients

    Seq Age Sex Outcome Treatment
    1 Other