BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIONS PREMIER TORIC

    MDR report key: 3842816 · Received January 31, 2014

    Report

    Report Number
    9614392-2014-00002
    Event Type
    Injury
    Date Received
    January 31, 2014
    Date of Event
    December 24, 2013
    Report Date
    January 5, 2014
    Manufacturer
    COOPERVISION MANUFACTURING, LTD.
    Product Code
    LPM
    PMA / PMN Number
    P080011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ASSOCIATION BETWEEN COOPERVISION LENS AND THE EVENT IS UNCONFIRMED. THE LENS WAS NOT RETURNED AND THE LOT NUMBER IS UNK. SUBMISSION OF A REPORT DOES NOT CONSTITUTE AND ADMISSION THAT MEDICAL PERSONNEL OR THE PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    COOPERVISION WAS MADE AWARE ON (B)(6) 2014 BY (B)(6) OF A PT WHO ON (B)(6) 2013 WAS DIAGNOSED WITH A CORNEAL ULCER WHILE WEARING OPTIONS PREMIERE TORIC CONTACT LENSES. MEDICAL INFO RECEIVED FROM THE OPTICIAN RELATES ONSET SYMPTOMS OF RIGHT EYE SORENESS AND REDNESS AND 1 DAY OF PHOTOPHOBIA. EXAM RELATES THE RIGHT EYE AS GROSS CONJUNCTIVAL INJECTION, CLOUDY ANTERIOR CHAMBER, LIDS SWOLLEN AND PARACENTRAL CORNEAL ULCER. NO EXAMINATION WAS DESCRIBED FOR THE LEFT EYE. THE PT WAS REFERRED TO HOSPITAL AND WAS PRESCRIBED ANTIBIOTIC/STEROID EYE DROPS FOR ONE WEEK. THE OPTICIAN REPORT RELATES PERMANENT DAMAGE TO BODY STRUCTURE AS CORNEAL SCAR WITH MEDICAL INTERVENTION REQUIRED. PT WAS TEMPORARILY DISCONTINUED FROM CONTACT LENS WEAR ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67646 OPTIONS PREMIER TORIC OPTIONS PREMIER TORIC (COMFILCON A) LPM COOPERVISION MANUFACTURING, LTD. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention