BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAIRA TORIC, ENAFILCON A

    MDR report key: 3322698 · Received August 28, 2013

    Report

    Report Number
    2640128-2013-00009
    Event Type
    Injury
    Date Received
    August 28, 2013
    Date of Event
    August 12, 2011
    Report Date
    August 12, 2013
    Manufacturer
    COOPER VISION CARRIBBEAN CORP
    Product Code
    LPM
    PMA / PMN Number
    P080011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO LENSES OR LOT NUMBERS WERE RETURNED FOR EVAL. THE COMPLAINT IS UNCONFIRMED.

    Description of Event or Problem · 1

    PT STATES THAT ON OR ABOUT (B)(6) 2010 WERE FIRST PRESCRIBED AVAIRA TORIC LENSES BY PHYSICIAN. PT STATES THAT WAS PRESCRIBED AT VARIOUS TIMES, AND USED, AVAIRA CONTACT LENS WITHOUT ISSUE UNTIL (B)(6) 2011 WHEN FIRST BEGAN SUFFERED PAIN AND IRRITATION IN HIS RIGHT EYE AND PRESENTED TO PHYSICIANS FOR EVAL. PT STATES THAT ON (B)(6) 2011, WAS DIAGNOSED WITH A CORNEAL ULCER AND TREATED WITH TOPICAL OINTMENT. PT STATES THAT ON (B)(6) 2011, WAS EVALUATED AND DETERMINED TO HAVE AN ULCERATION WHICH EXTENDED INTO THE STROMA WITH A LESION OF APPROX 3-4 MM IN SIZE WITH THE DEFECT LOCATED IN THE INFERIOR CORNEA WITH POSITIVE FLUORESCEIN STAINING. PT STATES THAT ON (B)(6) 2012 WAS ADVISED BY PHYSICIAN THAT HE SUFFERED CORNEAL SCARRING AND OPACITIES AS A RESULT OF THE LENS. PT STATES THAT HAS BEEN INJURED AND SUSTAINED SEVERE AND PERMANENT PAIN, SUFFERING, DISABILITY, AND IMPAIRMENT. NEITHER MEDICAL EVAL RECORD NOR FURTHER DETAILS WERE PROVIDED. THE LENSES WERE NOT RETURNED. LOT NUMBERS FOR THE LENSES WERE NOT PROVIDED. THIS EVENT IS REPORTED WITH ABUNDANCE OF CAUTION BECAUSE THE EXTENT OF THE CORNEAL ULCER AND/OR TREATMENT IS UNK FROM WHICH TO RULE OUT PERMANENT IMPAIRMENT OF EYE FUNCTION OR DAMAGE TO BODY STRUCTURE, OR THAT THE MEDICAL TREATMENT PROVIDED WAS TO PRECLUDE PERMANENT IMPAIRMENT OF EYE FUNCTION OR DAMAGE TO BODY STRUCTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421856 AVAIRA TORIC, ENAFILCON A LPM, SOFT CONTACT LENS, DAILY WEAR LPM COOPER VISION CARRIBBEAN CORP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Other