BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 2133609 · Received June 16, 2011

    Report

    Report Number
    1314956-2011-00007
    Event Type
    Injury
    Date Received
    June 16, 2011
    Report Date
    May 18, 2011
    Manufacturer
    COOPERVISION, INC.
    Product Code
    LPL
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT WAS INITIALLY REPORTED BY THE PT. COOPERVISION F/U INCLUDES SEVERAL E-MAILS, A PHONE CALL AND A LETTER. IT IS UNK WHICH PRODUCT WAS INVOLVED OR WHICH EYE. NO ADDITIONAL INFORMATION HAS BEEN REC'D DESPITE SEVERAL REQUESTS TO THE PT. 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 EVENT. CONCLUSION: BASED ON STATEMENTS BY THE PT, THE PT SUFFERED AN EYE INFECTION AND TEMPORARY BLINDNESS. 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 E-MAILED COOPERVISION ON (B)(6), 2011. PT STATED THAT ONE OF HER CONTACT LENSES HAD A CUT ON THE OUTSIDE OF THE LENS. THE PT STATED SHE REC'D A CUT ON HER EYE AS A RESULT OF THE LENS. PT STATED THAT TEMPORARY BLINDNESS OCCURRED AS THE EYE BECAME INFECTED. SINCE COOPERVISION BECAME AWARE OF THIS INCIDENT, COOPERVISION HAS ATTEMPTED TO CONTACT THE PT ON FIVE DIFFERENT OCCASIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK UNK LPL COOPERVISION, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other