BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTEX TORIC (METHAFILCON A)

    MDR report key: 1910235 · Received November 17, 2010

    Report

    Report Number
    9614392-2010-00015
    Event Type
    Injury
    Date Received
    November 17, 2010
    Report Date
    October 24, 2010
    Manufacturer
    COOPERVISION MANUFACTURING LIMITED
    Product Code
    LPM
    PMA / PMN Number
    P850079
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    LENSES WERE RETURNED, BUT NOT THE LOT THE PATIENT WAS WEARING AT THE TIME OF THE INCIDENT. THE LOT WORN AT THE TIME OF THE INCIDENT IS UNKNOWN. 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: WE ARE REPORTING THIS BECAUSE WE CANNOT CONFIRM THAT THERE WAS NO PERMANENT IMPAIRMENT OR PERMANENT DAMAGE. THERE IS NO CLEAR INDICATION THAT THE DEVICE COULD HAVE CAUSED OR CONTRIBUTED TO THE INCIDENT. CONCLUSIONS: NO CONCLUSION CAN BE DRAWN. INVESTIGATION IS ON-GOING. SHOULD RESULTS OF INSPECTION 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

    ON OCTOBER 24TH, COOPERVISION RECEIVED A PRODUCT RETURN FORM WITH A NOTE STATING THE LENS CAUSED A PATIENT TO HAVE ULCERS. THE LENSES RETURNED WERE UNOPENED BOXES, AND NOT THE LOTS THE PATIENT HAD BEEN WEARING AT THE TIME OF THE INCIDENT. THE LOT WORN AT THE TIME OF INCIDENT IS UNKNOWN. ON NOVEMBER 8TH, IT WAS DETERMINED THE ULCER WAS ONLY IN ONE EYE. THE STAFF STATED THE ULCER WAS NOT CENTRAL AND NOT BIG IN SIZE. NO CULTURES WERE DONE. STAFF WAS NOT ABLE TO CONFIRM WHICH EYE THE INCIDENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERTEX TORIC (METHAFILCON A) LPM, SOFT CONTACT LENS, EXTENDED WEAR LPM COOPERVISION MANUFACTURING LIMITED UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other