BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFMED BREATHABLE TORIC (ENFILCON A)

    MDR report key: 2190674 · Received July 26, 2011

    Report

    Report Number
    2640128-2011-00005
    Event Type
    Injury
    Date Received
    July 26, 2011
    Date of Event
    June 24, 2011
    Report Date
    July 7, 2011
    Manufacturer
    COOPERVISION CARIBBEAN CORP
    Product Code
    LPL
    PMA / PMN Number
    K071736
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT WAS REPORTED AS A CORNEAL ULCER IN THE LEFT EYE BY THE EYE CARE PRACTITIONERS OFFICE TO COOPERVISION. METHOD: FOUR (4) UNOPENED LENSES FROM SAME LOT OF THE ACTUAL DEVICE INVOLVED IN THE INCIDENT WERE RETURNED AND EVALUATED. THE DEVICE WAS EXAMINED FOR VISUAL DEFECTS AND MEASURED FOR PARAMETERS. RESULTS: THERE IS NO DIRECT CAUSAL RELATIONSHIP ESTABLISHED BETWEEN THE MEDICAL DEVICE AND THE INCIDENT THE PT COMPLAINS OF. CONCLUSIONS: NO FAILURE WAS DETECTED AND THE PRODUCT WAS WITHIN SPECS. NO CONCLUSION CAN BE DRAWN. SHOULD FURTHER INFO BE PROVIDED THAT WOULD CHANGE THIS CONCLUSION, AN UPDATE TO THIS REPORT WILL BE PROVIDED WITHIN ONE MONTH OF RECEIPT OF THE ADD'L INFO.

    Description of Event or Problem · 1

    PT WAS PRESCRIBED SOFMED BREATHABLE TORICS (ENFILCON A). ON (B)(6) 2011, PT WAS DIAGNOSED WITH AN ULCER IN HER LEFT EYE AND WAS REFERRED TO A LOCAL OPHTHALMOLOGIST. PT WAS EXPERIENCING PAIN AND LIGHT SENSITIVITY. PT TEMPORARILY DISCONTINUED CONTACT LENS USE FROM (B)(6) 2011 AND WAS PRESCRIBED TOBRADEX. THERE WAS NO ALTERATION OF LENS CARE REGIMEN, NO REDUCTION IN VISUAL ACUITY, AND THE ULCER HAS FULLY RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFMED BREATHABLE TORIC (ENFILCON A) LPL, SOFT CONTACT LENS, DAILY WEAR LPL COOPERVISION CARIBBEAN CORP 5627500319041014

    Patients

    Seq Age Sex Outcome Treatment
    1 Other