BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCLEAR TORIC OMAFILCON A

    MDR report key: 2922618 · Received January 18, 2013

    Report

    Report Number
    9614392-2013-00002
    Event Type
    Injury
    Date Received
    January 18, 2013
    Date of Event
    December 5, 2012
    Report Date
    December 9, 2012
    Manufacturer
    COOPERVISION MANUFACTURING LIMITED
    Product Code
    LPL
    PMA / PMN Number
    K952152
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS BEING FILED AS A FOLLOW UP CORRECTION. B THE DATE OF THE REPORT WAS CORRECTED. NO PRODUCT WAS RETURNED FOR EVALUATION. SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL OR THE PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT. (B)(4): NO PRODUCT RETURNED.

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL OR THE PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT. (B)(4): NO PRODUCT RETURNED.

    Description of Event or Problem · 1

    COOPERVISION WAS MADE AWARE OF A PATIENT WHO EXPERINCED CORNEAL VASCULAR INVASION DUE TO OVERWEAR OF THE LENSES. IT IS NOTED THAT THE PATIENT WORE THE LENSES FOR 2 CONSECUTIVE YEARS, EVEN THOUGH HE WAS AWARE THAT THEY WERE FOR 6 MONTH USE. THE PATIENT WAS ADVISED TO DISCONTINUE CONTACT LENS WEAR AND USE GLASSES. THE PATIENT IS NOW USING A DIFFERENT BRAND OF LENSES. THE PATIENT'S CURRENT CONDITION IS REPORTED AS RECOVERED HOWEVER TH EXTENT OF THE CORNEAL VASCULAR INVASION WAS NOT NOTED. FOLLOW UP ATTEMPTS HAVE BEEN MADE FOR MORE INFORMATION, WITH NO REPLY TO DATE.

    Description of Event or Problem · 1

    COOPERVISION WAS MADE AWARE OF A PATIENT WHO EXPERIENCED CORNEAL VASCULAR INVASION DUE TO OVER WEAR OF THE LENSES. IT IS NOTED THAT THE PATIENT WORE THE LENSES FOR 2 CONSECUTIVE YEARS, EVEN THOUGH HE WAS AWARE THAT THEY WERE FOR 6 MONTH USE. THE PATIENT WAS ADVISED TO DISCONTINUE CONTACT LENS WEAR AND USE GLASSES. THE PATIENT IS NOW USING A DIFFERENT BRAND OF LENSES. THE PATIENT'S CURRENT CONDITION IS REPORTED AS RECOVERED HOWEVER THE EXTENT OF THE CORNEAL VASCULAR INVASION WAS NOT NOTED. FOLLOW UP ATTEMPTS HAVE BEEN MADE FOR MORE INFORMATION, WITH NO REPLY TO DATE. THIS IS BEING FILED AS A CORRECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27430 PROCLEAR TORIC OMAFILCON A LPL, SOFT CONTACT LENS, DAILY WEAR LPL COOPERVISION MANUFACTURING LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention