BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRESHLOOK COLORBLENDS UV

    MDR report key: 2993876 · Received March 1, 2013

    Report

    Report Number
    1422160-2013-00001
    Event Type
    Injury
    Date Received
    March 1, 2013
    Report Date
    February 3, 2013
    Manufacturer
    CIBA VISION CORPORATION DES PLAINES
    Product Code
    LPM
    PMA / PMN Number
    P830037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT WAS NOT RETURNED FOR EVALUATION. REVIEW OF THE DEVICE HISTORY RECORDS AND STERILIZATION RECORDS ARE IN PROGRESS. INTERNAL CONTROL NUMBER: (B)(4).

    Description of Event or Problem · 1

    AS REPORTED BY THE PATIENT'S MOTHER, THE PATIENT EXPERIENCED AN INJURY IN THE RIGHT EYE DURING CONTACT LENS WEAR IN (B)(6) 2010. THE PATIENT HAS RECEIVED MEDICAL ATTENTION SINCE THAT TIME BUT THE CONDITION CONTINUES TO GET WORSE. THE PATIENT WAS TOLD TO BE DISCONTINUE LENS WEAR. STEM CELL SURGERY MAY BE NEEDED. ON (B)(6) 2013, ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT'S MOTHER. THE PATIENT HAS VISITED THE DOCTOR BUT AFTER SEVERAL FOLLOW-UP CARE VISITS THERE WAS NO IMPROVEMENT AND IT WAS RECOMMENDED THAT SHE VISIT A CORNEA SPECIALIST. THE CORNEAL SPECIALIST TREATED THE PATIENT WITH ORAL ANTIBIOTICS AND EYE DROPS BUT THERE WAS LITTLE IMPROVEMENT. THE PATIENT WAS REFERRED TO ANOTHER SPECIALIST. THE EYE DROPS WERE DISCONTINUED. THE PATIENT WAS TOLD THAT IT WOULD TAKE A LONG TIME FOR HER EYE TO HEAL. THE CONDITION WAS NOT IMPROVING AND THE PATIENT BEGAN TO HAVE ISSUES SEEING OUT OF THE RIGHT EYE. ON (B)(6) 2013, THE PATIENT REPORTED THAT THE DAY THE EVENT BEGAN, SHE HAD INSERTED A NEW PAIR OF LENSES IN THE AFTERNOON AND LATER THAT EVENING GOT A SHARP PAIN IN HER RIGHT EYE. SHE REMOVED THE LENSES, BUT THE PAIN WAS SO BAD SHE COULD BARELY SLEEP. SHE WENT TO THE DOCTOR WHO THOUGHT IT WAS ALLERGIES, BUT SHE WAS NOT TAKING MEDICATION FOR ALLERGIES. SHE DID NOT REINSERT ANY LENSES AND HAS NOT RESUMED LENS WEAR SINCE THE INCIDENT. SHE THEN WENT TO AN EYE CARE PROFESSIONAL (ECP) WHO GAVE HER AN ANTIBIOTIC DROP. SHE WAS SENSITIVE TO LIGHT, HER EYE WAS TEARING, BLURRY AND "FELT LIKE SARAN WRAP WAS OVER IT". ACCORDING TO THE PATIENT, THE EYE CARE PROFESSIONAL DID NOT KNOW WHAT WAS CAUSING IT SO SHE WENT TO A CORNEAL SPECIALIST WHO GAVE HER MORE ANTIBIOTICS. THE SPECIALIST NOTED SCARRING. THE PATIENT WAS TOLD BY THE SPECIALIST THAT THE CONTACT LENSES CAUSED THE EVENT AND SHE WAS DIAGNOSED WITH STEM CELL DEFICIENCY. DURING A FOLLOW UP VISIT IN (B)(6) 2013, THE SPECIALIST TOLD THE PATIENT THAT 80% OF HER EYE IS SCARRED. THE SPECIALIST WANTS TO TAKE THE STEM CELLS FROM HER LEFT EYE AND PUT IT INTO THE RIGHT EYE, BUT WITH THE AMOUNT NEEDED HE CAN ONLY DO A PARTIAL TRANSFER AS TO NOT LEAVE THE LEFT EYE WITH TOO FEW STEM CELLS. NO MEDICATIONS WERE PRESCRIBED AND THE PATIENT WAS INSTRUCTED NOT TO USE ANY DROPS. ON (B)(6) 2013, MEDICAL RECORDS RECEIVED INDICATED HER INITIAL PRESCRIPTION AND ORDER OF FRESHLOOK COLORBLENDS CONTACT LENSES ON (B)(6) 2010. THE RECORDS ALSO INDICATE THE FURTHER DETERIORATION OF THE EYE OF THE PATIENT NOTED ON THE FOLLOWING RESPECTIVE DATES: (B)(6) 2010, (B)(6) 2011, (B)(6) 2011, (B)(6) 2011, (B)(6) 2011, (B)(6) 2011, (B)(6) 2012 AND (B)(6) 2013. THE MEDICAL RECORDS FROM (B)(6) 2010, (B)(6) 2011, (B)(6) 2011 AND (B)(6) 2011 INDICATE THAT EYE CARE PROFESSIONALS ASSESSED AND TREATED THE PATIENT FOR (B)(6). ON THE (B)(6) 2011, FOLLOW UP VISIT THE PATIENT PRESENTED COMPLAINTS THAT THE VISION DECREASED SINCE THE PREVIOUS VISIT. SHE WAS SUBSEQUENTLY REFERRED TO THE CORNEA SPECIALIST DR. (B)(6) FOR FURTHER CONSULTATION. ON (B)(6) 2011, THE DOCTOR REPORTED THAT THE PATIENT REPORTED STINGING, BLURRY VISION, PHOTOPHOBIA, NOTICED SHARP PAIN, TEARING AND THE RIGHT EYE NO LONGER OPENING AS WIDE AS THE LEFT EYE. THE DOCTOR DIAGNOSED THE PATIENT WITH STEM CELL DEFICIENCY IN THE RIGHT EYE POSSIBLY DUE TO (B)(6) BUT MORE LIKELY DUE TO CONTACT LENS WEAR. THE DOCTOR PERMANENTLY DISCONTINUED CONTACT LENS WEAR AND PRESERVED DROPS FOR THE RIGHT EYE. ON (B)(6) 2011 AND (B)(6) 2012, NO CHANGES WERE NOTED IN THE CONDITION OF THE PATIENT. ON (B)(6) 2013, THE DOCTOR REPORTED PERSISTENT STEM CELL DEFICIENCY IN THE RIGHT EYE AND THE CONSIDERATION OF A TRANSPLANT OF LIMBUS FROM THE LEFT EYE TO SUPPLY LIMBUS TO THE RIGHT EYE IF NEEDED. ON (B)(6) 2013, THE PATIENT'S MOTHER REPORTED THAT THE PATIENT IS EXPERIENCING BLURRY VISION AT NIGHT. THE PATIENT'S EYES HURT WITH INTENSE PAIN. ACCORDING TO THE PATIENT'S MOTHER, THE PATIENT DOES NOT HAVE DIABETES AND OR ANY OTHER MEDICAL CONDITION. THE PATIENT STARTED WEARING CONTACT LENSES WHEN SHE WAS (B)(6). INITIALLY, SHE INSERTED THE CONTACT LENS IN THE MORNING AND IN THE EVENING SHE FELT EXTREME PAIN AND REMOVED THE CONTACT LENSES. SHE INSERTED A NEW LENS IN THE AFTERNOON AND TOOK THE CONTACT LENSES OFF IN THE EVENING AFTER PAIN. ON (B)(6) 2013, THE PATIENT REPORTED THAT THE VISION IN THE RIGHT EYE IS BAD AND THE LID OF THE RIGHT EYE DOESN'T OPEN AS WIDE AS THE LEFT. SHE CONFIRMED EVERYTHING HER MOTHER SAID AS WELL. THE PATIENT IS CURRENTLY NO LONGER ON ANY MEDICATION FOR THE EYE AND SHE IS WEARING GLASSES. ADDITIONAL HAS BEEN REQUESTED BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89521 FRESHLOOK COLORBLENDS UV LENSES, SOFT CONTACTS, EXTENDED WEAR LPM CIBA VISION CORPORATION DES PLAINES

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention