BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREQUENCY 55 TORIC (METHAFILCON B)

    MDR report key: 2030765 · Received March 21, 2011

    Report

    Report Number
    1314956-2011-00002
    Event Type
    Injury
    Date Received
    March 21, 2011
    Date of Event
    February 9, 2011
    Report Date
    February 28, 2011
    Manufacturer
    COOPERVISION, INC.
    Product Code
    LPL
    PMA / PMN Number
    K962185
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT WAS INITIALLY REPORTED BY THE PT. CVI FOLLOW UP INCLUDES VERBAL STATEMENTS FROM ECP. NO WRITTEN DOCUMENTATION HAS BEEN REC'D DESPITE REQUESTS TO THE ECP. NO PRODUCT HAS BEEN RETURNED OR LOT INFO PROVIDED. METHOD: NO LOT INFO, NO LENSES, NO DEVICE INFO, NO EXAMINATION OF DEVICE WAS PROVIDED WHICH COULD INDICATE IF THE DEVICE CAUSED OR CONTRIBUTED TO THE INCIDENT. RESULTS: THERE IS NO DIRECT CAUSAL RELATIONSHIP ESTABLISHED BETWEEN THE MEDICAL DEVICE AND THE INCIDENT THE PT COMPLAINS OF. CONCLUSION: NO CONCLUSION CAN BE DRAWN. SHOULD ADD'L INFO BE REC'D THAT WOULD CHANGE THIS CONCLUSION, AN UPDATE TO THIS REPORT WILL BE FILED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    PT WAS TREATED FOR A CORNEAL / EPITHELIAL DEFECT IN THE LEFT EYE ON (B)(6) 2011. THE LENSES WERE DISPENSED TO THE PT ON (B)(6) 2011. THE PT PUT IN A NEW LENS AND WITHIN HRS HER EYE WAS RED. SHE WENT TO HER O.D.'S OFFICE AND WAS TREATED WITH VIGAMOX AND "CELLUBIC" FOR 5 DAYS. LENS WEAR WAS DISCONTINUED FROM (B)(6) - (B)(6). THE DOCTOR TRIED A NEW LENS FROM THE SAME BOX AND THE PT STARTED TO HAVE THE SAME REACTION. NO TREATMENT WAS NEEDED THE SECOND TIME AS THE LENS WAS IMMEDIATELY REMOVED. THE PT'S BEST CORRECTIVE VISUAL ACUITY OF 20/20 HAS NOT CHANGED. THE PT HAS BEEN REFIT INTO A DIFFERENT CONTACT LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREQUENCY 55 TORIC (METHAFILCON B) LPL, SOFT CONTACT LENS, DAILY WEAR LPL COOPERVISION, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention