BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOFINITY TORIC COMFILCON A

    MDR report key: 2884035 · Received December 21, 2012

    Report

    Report Number
    9614392-2012-00102
    Event Type
    Injury
    Date Received
    December 21, 2012
    Report Date
    January 4, 2013
    Manufacturer
    COOPERVISION MANUFACTURING LIMITED
    Product Code
    LPM
    PMA / PMN Number
    P080011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS IDENTIFIED THAT COULD CONFIRM OR DENY THAT THIS WAS A COOPERVISION, INC. PRODUCT. THIS IS BEING FILED AS UNCONFIRMED SERIOUS ADVERSE EVENT.

    Description of Event or Problem · 1

    CVI (COOPERVISION, INC) RECEIVED A LETTER FROM A LAW OFFICE, ADDRESSED TO (B)(4), REPORTING AN ADVERSE EVENT THAT DID NOT IDENTIFY THE PRODUCT. (B)(4), THE PATIENT INSERTED A LENS AND WITHIN AN HOUR THE LEFT EYE BECAME PAINFUL AND BLOODSHOT. SHE REMOVED THE LENS AND NOTED THE LENS HAD SPLIT IN HALF. SHE THEN WHEN TO HER GENERAL PRACTITIONER WHO REFERRED HER TO AN INFIRMARY AND THEN A HOSPITAL FOR TREATMENT. THE INITIAL DIAGNOSIS WAS A CORNEAL ABRASION OF HER LEFT EYE. IT IS REPORTED HER VISION BEGAN TO DETERIORATE RESULTING IN VISION LOSS OF THE LEFT EYE. A CORNEAL SCRAPE WAS DONE ON (B)(6) 2011 AND WAS NOTED AS HAVING WORSENING CORNEAL INFILTRATE AND A HYPOPYON AS WELL AS EPITHELIAL DEFECT. A LEFT CORNEAL BIOPSY WAS PERFORMED ON (B)(6) 2011, LEFT KERATITIS AND LEFT UVEITIS WAS DIAGNOSED. SUBSEQUENT SECONDARY CATARACT OF THE LEFT EYE AS A RESULT OF THE SCARRING IS NOTED. ATTEMPTS TO CONTACT THE LAW OFFICE TO IDENTIFY THE PRODUCT WERE MADE WITH NO REPLY TO DATE. THE PRODUCT CANNOT BE CONFIRMED TO BE COOPERVISION, INC.

    Description of Event or Problem · 1

    PRODUCT INFORMATION BECAME AVAILABLE. THIS IS BEING FILED AS ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOFINITY TORIC COMFILCON A LPM, SOFT CONTACT LENS, EXTENDED WEAR LPM COOPERVISION MANUFACTURING LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Disability