BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOFINITY TORIC

    MDR report key: 3242898 · Received July 19, 2013

    Report

    Report Number
    9614392-2013-00041
    Event Type
    Injury
    Date Received
    July 19, 2013
    Date of Event
    April 14, 2013
    Report Date
    July 4, 2013
    Manufacturer
    COOPERVISION MANUFACTURING, LTD.
    Product Code
    LPM
    PMA / PMN Number
    P080011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE RETURNED WITH A DEVICE THAT WAS THE SUBJECT OF AN EARLIER COMPLAINT.

    Description of Event or Problem · 1

    COOPERVISION WAS MADE AWARE ON (B)(4) 2013 THAT ON OR AROUND A (B)(6) 2013 ECP VISIT, A (B)(6) YEAR OLD, FEMALE, WAS REVEALED TO HAVE RIGHT EYE BIOMICROSCOPY FINDINGS THAT INDICATED TRACE CORNEAL INFILTRATES, TRACE LIMBAL INJECTIONS, TRACE BULBAR INJECTION, TRACE TARSAL PAPILLAE, AND MODERATE GIANT PAPILLARY CONJUNCTIVITIS. THE PATIENT WAS TREATED WITH TOBRADEX (ANTIBIOTIC/ STEROID). THE MEDICAL COMPLAINT RESOLUTION WAS DESCRIBED AS, RESULTED IN PERMANENT REDUCTION IN VISUAL ACUITY. NO MEDICAL INTERVENTION WAS REQUIRED TO PRECLUDE IMPAIRMENT. THE LENS WAS RETURNED, INSPECTED, AND FOUND TO HAVE NO ISSUES. THE COMPLAINT IS UNCONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338253 BIOFINITY TORIC LPM COOPERVISION MANUFACTURING, LTD. 837800179

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other