BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOFINITY TORIC (COMFILCON A)

    MDR report key: 2121027 · Received June 9, 2011

    Report

    Report Number
    9614392-2011-00030
    Event Type
    Injury
    Date Received
    June 9, 2011
    Date of Event
    February 14, 2011
    Report Date
    May 19, 2011
    Manufacturer
    COOPERVISION MANUFACTURING LIMITED
    Product Code
    LPM
    PMA / PMN Number
    P080011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT WAS REC'D FROM EYE CARE PRACTITIONER TO COOPERVISION (B)(4). METHOD: NO LOT INFORMATION, NO LENSES, NO DEVICE INFORMATION, NO EXAMINATION OF DEVICE WERE PROVIDED WHICH COULD INDICATE IF THE DEVICE CAUSED OR CONTRIBUTED TO THE INCIDENT. RESULTS: THERE IS NO CLEAR INDICATION THAT THE DEVICE COULD HAVE CAUSED OR CONTRIBUTED TO THE INCIDENT. RESULTS: THERE IS NO CLEAR INDICATION THAT THE DEVICE COULD HAVE CAUSED OR CONTRIBUTED TO THE EVENT. CONCLUSIONS: NO CONCLUSION CAN BE DRAWN. SHOULD FURTHER INFORMATION BE PROVIDED THAT WOULD CHANGE THIS CONCLUSION, AN UPDATE TO THIS REPORT WILL BE PROVIDED WITHIN ONE MONTH OF RECEIPT OF THE ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    PT IS NEW TO CONTACT LENSES. PT WAS FITTED WITH BIOFINITY TORIC TRIAL LENSES ON (B)(6), 2011. ON (B)(6), 2011, THE PT WOKE WITH A PAINFUL AND SWOLLEN LEFT EYE AND RETURNED TO THE EYE CARE PRACTITIONER. ON (B)(6), 2011, THE PT WAS DIAGNOSED WITH TWO CORNEAL ULCERS IN THE LEFT EYE, SIGNIFICANT EPITHELIAL CHANGE, MINOR INFILTRATES AND CONJUNCTIVITIS (ALL IN THE LEFT EYE). THE PT HAD BEEN SLEEPING IN THE LENSES. THE PT WAS PRESCRIBED CHLOROMYCETIN AND FML EYE DROPS. THE PT PERMANENTLY DISCONTINUED LENS WEAR. THE PT HAS MADE A FULL RECOVERY AND THE OPTICIAN BELIEVES IT WAS A RESULT OF THE PT SLEEPING IN THE LENSES.

    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 Other