BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNKNOWN

    MDR report key: 2123344 · Received November 21, 2008

    Report

    Report Number
    3005087645-2008-00005
    Event Type
    Other
    Date Received
    November 21, 2008
    Date of Event
    August 1, 2008
    Report Date
    November 20, 2008
    Manufacturer
    SYNERGEYES, INC.
    Product Code
    HQD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    COULD NOT VERIFY IF LENS IS SYNERGEYES, INC. LENS. DR. NOT RESPONSIVE. NO COMMENT FROM THIS DOCTOR. PT. HAD CORNEAL GRAFT PRIOR TO RECEIVING LENS. COMPLICATION RARE BUT NOT UNKNOWN, NO EVIDENCE OF MALFUNCTION OF THE DEVICE BUT RATHER AN INHERENT RISK OF CONTACT LENS WEAR. IN THE INSTRUCTIONS FOR USE FOR THE LENSES IT STATES: "IF A PATIENT EXPERIENCES EYE DISCOMFORT, EXCESSIVE TEARING, VISION CHANGES, OR REDNESS OF THE EYE, THE PATIENT SHOULD BE INSTRUCTED TO IMMEDIATELY REMOVE LENS AND PROMPTLY CONTACT HIS OR HER EYE CARE PRACTITIONER." THE INSTRUCTIONS FOR USE ALSO STATES: "EYE CARE PRACTITIONERS SHOULD INSTRUCT THE PATIENT TO REMOVE THE LENSES IMMEDIATELY IF THE EYES BECOME RED OR IRRITATED." THERE HAS BEEN NO FURTHER FOLLOW-UP FROM EITHER THE PATIENT OR THE PRACTITIONER (NO CONTACT).

    Description of Event or Problem · 1

    THE PATIENT E-MAILED THE WEBSITE WITH REGARDS TO AN ISSUE WITH THE LENS. THE PATIENT DID NOT SPEAK DIRECTLY TO A SPOKESPERSON. THE PATIENT WROTE "I HAVE HAD CORNEA TRANSPLANT IN BOTH MY EYES DUE TO KERATOCONUS. A YEAR AND A HALF AGO ONE OF THE OPTS FITTED ME WITH SYNERGEYES. TWO MONTHS AGO I DEVELOPED DISCOMFORT AND SWELLING IN MY RIGHT EYE THAT LEAD TO GRAFT REJECTION. MY DOCTOR TOLD ME THAT THE SYNERGEYES LENS BLOCKS OXYGEN TO THE CORNEA, NOT ONLY THAT, OVER THE LAST 1 1/2 YEARS I HAVE DEVELOPED VEINS IN MY CORNEA BECAUSE OF THIS LENS." THE COMPLAINT FOLLOW-UP FORM WAS FAXED TO THE PRACTITIONER'S OFFICE SEVERAL TIMES IN ATTEMPT TO GET FURTHER INFORMATION WITH NO RESPONSE. WEEK 1: FAX TO PRACTITIONER'S OFFICE. WEEK 2: REFAX TO PRACTITIONER'S OFFICE. WEEK 3: FEDEX TO PRACTITIONER'S OFFICE. WEEK 4: PHONE CONTACT TO PRACTITIONER'S OFFICE/E-MAIL TO DR. ATTENDING DOCTOR COULD NOT BE REACHED AFTER SEVERAL ATTEMPTS. THIRTY (30) DAYS IS NEARING AND THE REPORT OF SERIOUS INJURY NEEDS TO BE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN CONTACT LENS HQD SYNERGEYES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention