BEUDAMED
    FDA Adverse Event Other Summary report: N

    PREFERENCE SPHERE

    MDR report key: 1068826 · Received July 2, 2008

    Report

    Report Number
    1314956-2008-00002
    Event Type
    Other
    Date Received
    July 2, 2008
    Date of Event
    December 6, 2007
    Report Date
    June 6, 2008
    Manufacturer
    COOPERVISION, INC.
    Product Code
    LPM
    PMA / PMN Number
    N17679
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LENS FROM THE SAME LOT AS ACTUAL DEVICE AND THE LOT HISTORY RECORD, STERILIZATION RECORD AND SALINE BATCH RECORD WERE EXAMINED. THE LENS MEASUREMENTS AND PACKAGE SALINE PH WERE ALL WITHIN TOLERANCE. STERILIZATION CYCLE INDICATED THE PRODUCT WAS STERILE. INITIAL REPORT BY PHYSICIAN'S OFFICE ON 04/04/2008, INDICATED A VIRAL INFECTION, LIKELY TO BE A HERPES INFECTION OF THE EYE (SAME AS THE PATIENT'S SON). NO INDICATION IT COULD BE RELATED TO CONTACT LENS WEAR. BASED ON INFORMATION PROVIDED AT THAT TIME, CONCLUSION WAS THE INCIDENT DID NOT MEET THE MINIMUM CRITERIA FOR A REPORTABLE SERIOUS INCIDENT. ON 06/06/2008, AFTER REPEATED REQUEST, PHYSICIAN SUBMITTED A COMPLETED MEDICAL INCIDENT REPORT. ON THAT DATE COOPERVISION, INC. BECAME AWARE THAT THE INCIDENT MAY MEET THE MINIMUM CRITERIA FOR A REPORTABLE SERIOUS INCIDENT. NEW INFORMATION INDICATED THAT THE INFECTION MAY HAVE BEEN RECURRING. THIS IS BASED ON THE NUMBER VISITS (4) AND THE FACT THAT LENS WEAR WAS REPORTABLE DISCONTINUED FOR A PERIOD OF APPROX. 8 MONTHS ((B) (6) 2007 TO (B) (6) 2008). THE RX PRESCRIBED (TOBRADEX) WAS CONTRAINDICATED FOR HERPES OF THE EYE AND IS INDICATIVE OF A BACTERIAL INFECTION. THE REPORT INDICATES THE PATIENT'S SYMPTOMS WENT AWAY AFTER CHANGING TO A DIFFERENT LENS AND THERE IS NO REPORT OF PERMANENT DAMAGE. THE PATIENT'S VA BEFORE AND AFTER THE EVENT IS REPORTED AS 20/20 IN BOTH EYES. THIS CASE IS CONSIDERED TO BE A POSSIBLE RECURRING EYE INFECTION. THE CAUSE OF THE EVENT IS NOT KNOWN AND THE TREATING PHYSICIAN INDICATES THAT IT IS KNOWN IF IT IS RELATED TO LENS WEAR. BASED ON INFORMATION PROVIDED TO DATE, THERE IS NO CLEAR INDICATION THAT THE DEVICE COULD HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S CONDITION.

    Description of Event or Problem · 1

    PHYSICIAN'S OFFICE REPORTS PATIENT HAD INFECTION/ULCERS ON EYE. BEING TREATED FOR VIRAL INFECTION. MEDICAL INCIDENT REPORT FORM RETURNED ON (B) (6) 2008, INDICATES THAT PATIENT WAS SEEN 4 TIMES OVER AN 8-MONTH PERIOD FOR RED EYE AND DIAGNOSED ON (B) (6) 2007 WITH 1-2 NON-SPECIFIC BASED INJECTIONS (TINY SPOT OF STAINING IN CENTRAL CORNEA AREA). RX FOR PAIN (NOT IDENTIFIED) AND TOBRADEX. LENS WEAR DISCONTINUED FROM (B) (6) 2007 TO (B) (6) 2008. PATIENT FULLY RECOVERED AFTER CHANGING TO A DIFFERENT LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PREFERENCE SPHERE TETRAFILCON A SOFT CONTACT LENS LPM COOPERVISION, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention OPTIFREE/OCCASIONAL DISINFECTION W/CLEARCARE