BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCLEAR 1 DAY (OMAFILCON A)

    MDR report key: 1651874 · Received April 5, 2010

    Report

    Report Number
    9614392-2010-00004
    Event Type
    Injury
    Date Received
    April 5, 2010
    Date of Event
    February 1, 2010
    Report Date
    March 8, 2010
    Manufacturer
    COOPERVISION
    Product Code
    MVN
    PMA / PMN Number
    K061948
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT WAS REPORTED BY LETTER FROM PATIENT TO DISTRIBUTOR. INFORMATION ON TWO LOT NUMBERS WAS PROVIDED. LOT 3612064955, EXP 08/2014 AND 3612022344, EXP 06/2012. IT IS UNKNOWN WHICH LOT IS INVOLVED IN THE INCIDENT. THE PATIENT REPORTED ONE ULCER. IT IS UNKNOWN WHICH EYE IS INVOLVED IN THE INCIDENT. ONE RETURNED LENS FROM THE SAME LOT WAS INSPECTED AND MEASURED OUT OF SPECIFICATION FOR POWER. THE DEVICE WAS OUT OF SPECIFICATION BUT THIS DOES NOT RELATE TO THE EVENT. A REVIEW OF THE MANUFACTURING AND PRODUCTION HISTORIES FOR THE 2 LOTS DID NOT ESTABLISH ANY CONCLUSIVE EVIDENCE THAT THE DEVICE COULD HAVE CONTRIBUTED TO OR CAUSED THE CONDITION COMPLAINED OF. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL. THE RECORD REVIEW DID NOT FIND ANYTHING TO INDICATE THAT EITHER LOT COULD HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S COMPLAINT. THERE IS NO SUFFICIENT INFORMATION PROVIDED TO DRAW A CONCLUSION AS TO WHETHER OR NOT THE DEVICE COULD HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S COMPLAINT. THIS CASE IS CONSIDERED TO BE A POSSIBLE CORNEAL ULCER WITH TREATMENT AT A HOSPITAL. TO DATE THERE IS NO CONFIRMATION OF INJURY, TREATMENT OR OUTCOME OF TREATMENT. THERE IS NO CLEAR INDICATION THAT THE DEVICE COULD HAVE CAUSED OR CONTRIBUTED TO THE INCIDENT. SHOULD ADDITIONAL INFORMATION BE RECEIVED THAT WOULD CHANGE THIS CONCLUSION, AN UPDATE TO THIS REPORT WILL BE FILED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    PATIENT HAS BEEN TOLD THEY HAVE AN ULCER ON THEIR CORNEA. PATIENT STATES HE/SHE HAS BEEN GIVEN MEDICATION FROM THE HOSPITAL AND WAS TOLD TO REFRAIN FROM WEARING THE LENS AND TO USE GLASSES UNTIL THE ULCER CLEARS UP. PATIENT WAS AFTERCARE CONSULTATIONS AND CHECK UPS SCHEDULED WITH THEIR OPTICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROCLEAR 1 DAY (OMAFILCON A) LENS, CONTACT, (DISPOSABLE) MVN COOPERVISION UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O