BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARITI 1 DAY MULTIFOCAL (SOMOFILCON A)

    MDR report key: 8519404 · Received April 16, 2019

    Report

    Report Number
    3009108089-2019-00001
    Event Type
    Injury
    Date Received
    April 16, 2019
    Report Date
    April 16, 2019
    Manufacturer
    COOPERVISION CL KFT
    Product Code
    MVN
    PMA / PMN Number
    K130331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    LOT HISTORY, DEVICE HISTORY, STERILIZATION RECORDS AND TREND REPORTING WERE REVIEWED, INCLUDING DRY MANUFACTURING AND WET MANUFACTURING PROCESS. MANUFACTURER'S INVESTIGATION (B)(4) WAS RAISED TO FURTHER INVESTIGATE THE INCIDENT. IT WAS FOUND THAT THERE WAS A TEMPERATURE ISSUE DURING THE CURING PROCESS WHICH CAN LEAD TO INCORRECT BASE CURVE MEASUREMENTS. HOWEVER, DURING QUALITY INSPECTION AND PHYSICAL TESTING OF THE MANUFACTURED LOT, NO ISSUES WERE IDENTIFIED. THE DEFECT IDENTIFIED, INCORRECT BASE CURVE, IS CONSIDERED MINOR WITH A SEVERITY RATING OF 2 OUT OF 5 AS THERE IS A MINOR RISK TO OCULAR HEALTH OF THE USER OR MINOR EFFECT ON DEVICE FUNCTION WHICH MAY CAUSE THE USER DISSATISFACTION BUT NOT NORMALLY RESULT IN AN INJURY OR ILLNESS. THERE WERE (B)(4) LENSES MANUFACTURED FROM THIS LOT AND NO ADDITIONAL COMPLAINTS HAVE BEEN RECEIVED. WITH THREE LENSES BEING IDENTIFIED AS OUT OF TOLERANCE, THE INCIDENT IS OCCURRING AT (B)(4) WHICH IS CONSIDERED LOW ((B)(4)) AND GIVEN A PROBABILITY OF FAILURE RANKING OF 2 OUT OF 5. BASED ON THE MANUFACTURERS RISK ASSESSMENT AND CAPA TRIGGER MATRIX NO FURTHER ACTION IS REQUIRED. COOPERVISION DOES NOT PLAN TO TAKE ANY FORMAL REMEDIAL CORRECTIVE OR PREVENTATIVE ACTION, INCLUDING FIELD SAFETY CORRECTIVE ACTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THAT REQUIRES CORRECTIVE OR PREVENTATIVE ACTION, INCLUDING ANY NECESSARY FIELD SAFETY CORRECTIVE ACTION, COOPERVISION WILL INFORM FDA VIA A FOLLOW-UP REPORT. AS THE USED LENSES DIRECTLY INVOLVED IN THE INCIDENT WERE NOT RETURNED TO THE MANUFACTURER, IT IS UNCLEAR IF THE LENSES INVOLVED WERE SUBJECT TO A DEVICE MANUFACTURING DEFICIENCY, FAILURE, OR MALFUNCTION.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT WAS EXPERIENCING AN ALLERGIC TYPE REACTION WITH SYMPTOMS OF EYE PAIN, ITCHING, AND TEARING SINCE (B)(6) 2018. THE PATIENT SAW A PHARMACIST AND WAS GIVEN OPTREX (SODIUM HYALURONATE) EYE DROPS. THE PATIENT SOUGHT MEDICAL ASSISTANCE THREE DAYS LATER AT SPECSAVERS AND WAS INSTRUCTED TO CONTINUE USE WITH THE DROPS. ON 19 NOVEMBER THE PATIENT SAW A SPECIALIST AS THE CONDITION HAD NOT IMPROVED. EXAMINATION REVEALED MODERATE PUNCTATE STAINING OF BOTH CORNEAS, MILD CORNEAL INFILTRATES, GRADE THREE EPITHELIAL EDEMA, AND SEVERE LIMBAL AND BULBAR INJECTION AND TARSAL PAPILLAE. THE TREATING PHYSICIAN INDICATES SIGNIFICANT PAPILLARY CONJUNCTIVITIS AND LIMBITIS AS WELL AS CONJUNCTIVA INJECTION AND PUNCTATE KERATOPATHY. THE PATIENT WAS PRESCRIBED DEXAMETHASONE 1% AND INSTRUCTED TO DISCONTINUE CONTACT LENS WEAR FOR TWO WEEKS. THE PATIENT RESUMED LENS USE BUT EXPERIENCED SIMILAR SYMPTOMS. THE TREATING PHYSICIAN RECOMMENDED ONE MORE WEEK OF STEROID USE VIA EMAIL. ON (B)(6) 2018 THE PATIENT WORE A PAIR OF OLD CONTACT LENSES WHICH WERE SINGLE VISION, NOT THE PRESCRIBED MULTIFOCAL, AND EXPERIENCED NO REACTION. WHEN RETURNING TO THE USE OF THE MULTIFOCAL LENSES, THE PATIENT CONTINUES TO EXPERIENCE A SIMILAR REACTION. THE INCIDENT HAS SINCE RESOLVED, THE PATIENT HAS BEEN PRESCRIBED A DIFFERENT DAILY DISPOSABLE PRODUCT, BRAND OR MANUFACTURER UNKNOWN, AND IS CONTINUING LENS USE WITHOUT INCIDENT. THEY PHYSICIAN INDICATES THAT THE PATIENT'S CONDITION IN (B)(6) 2018 NECESSITATED THE USE OF MEDICAL INTERVENTION AND MEDICATION TO PREVENT OR PRECLUDE PERMANENT IMPAIRMENT OF EYE FUNCTION OR STRUCTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310597 CLARITI 1 DAY MULTIFOCAL (SOMOFILCON A) CLARITI 1 DAY MULTIFOCAL (SOMOFILCON A) MVN COOPERVISION CL KFT S0082997

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other| R