BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARITI 1 DAY TORIC (SOMOFILCON A)

    MDR report key: 15826075 · Received November 18, 2022

    Report

    Report Number
    3009108089-2022-00002
    Event Type
    Injury
    Date Received
    November 18, 2022
    Date of Event
    September 16, 2022
    Report Date
    November 18, 2022
    Manufacturer
    COOPERVISION CL KFT
    Product Code
    MVN
    PMA / PMN Number
    K130331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEVICE SAMPLE WAS RETURNED FOR MANUFACTURER ANALYSIS. NO ROOT CAUSE COULD BE ESTABLISHED. THE RELATIONSHIP BETWEEN THE COOPERVISION DEVICE AND THE INCIDENT IS UNCONFIRMED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, COOPERVISION WILL COMPLETE ADDITIONAL INVESTIGATIONS AND SUBMIT A FOLLOW-UP REPORT AS APPROPRIATE. AS THE PATIENT HAS EXPERIENCED IN INCIDENT IN BOTH RIGHT AND LEFT EYE, PLEASE REFER TO MANUFACTURER REPORT 3012123291-2022-00005 (B)(4) FOR LINKED INCIDENT.

    Description of Event or Problem · 0

    IT WAS INITIALLY REPORTED BY THE USER/PATIENT'S MOTHER THAT THE CONTACT LENSES WERE CAUSING REDNESS, THE USER SOUGHT MEDICAL TREATMENT AND WAS PRESCRIBED UNSPECIFIED EYE DROPS. ADDITIONAL INFORMATION PROVIDED BY THE TREATING ECP(S). THE PATIENT WAS SEEN FOR SEVERAL VISITS BETWEEN (B)(6) 2022 AND (B)(6) 2022 AT (B)(6) 2022 EYE CARE. THE PATIENT PRESENTED (B)(6) 2022 WITH REDNESS AND IRRITATION. THE PATIENT REPORTS THEY HAD PREVIOUSLY BEEN SEEN AT AN URGENT CARE FACILITY ON (B)(6) 2022, LOCATION UNSPECIFIED, WHERE THEY WERE DIAGNOSED WITH A CORNEAL ABRASION WHICH WAS NOT RESOLVING. THE URGENT CARE FACILITY ERYTHROMYCIN. PATIENT CONTINUED TO WEAR CONTACT LENSES AND EXPERIENCED PAIN AND LIGHT SENSITIVITY. EXAM SHOWED MODERATE LEFT (OS) EYE CONJUNCTIVAL STAINING, EPITHELIAL AND STROMAL EDEMA, AND LIMBAL INJECTION WITH A PARACENTRAL CORNEAL STAIN. ON (B)(6) 2022 PATIENT WAS DIAGNOSED WITH SECONDARY CORNEAL EDEMA, LEFT EYE, SECONDARY NON-INFECTIOUS IRIDOCYCLITIS, AND PUNCTATE KERATITIS AND PRESCRIBED TOBRAMYCIN DEXAMETHASONE AND ZYLET OPHTHALMIC SOLUTION. ECP STATES THAT AS OF 20 OCTOBER PATIENT CONTINUES TO EXPERIENCE REDNESS AND PAIN WITH SOME WHITE DISCHARGE IN THE LEFT EYE WITH NO VISION IMPACT AND DRY EYE. ECP STATES THE PATIENT HAS ALSO BEEN SEEN AT A DIFFERENT EYE CARE FACILITY (HORIZON EYE CARE) AND BY THEIR PAEDIATRICIAN FOR THESE ISSUES. INFORMATION RECEIVED FROM HORIZON EYE CARE TREATING PHYSICIAN, PATIENT WAS SEEN FOR ONE TRIAGE APPOINTMENT ON (B)(6) 2022. PATIENT WAS DIAGNOSED WITH CHRONIC BILATERAL CONJUNCTIVITIS WITH SYMPTOMS OF REDNESS AND IRRITATION. ECP NOTES FAINT CORNEAL STROMAL PUNCTATE OPACITIES IN THE LEFT (OS) EYE WITHOUT ANY SUPERFICIAL KERATOPATHY. PATIENT REPORTEDLY HAD AN ANTERIOR CHAMBER REACTION THE WEEK PRIOR IN THE RIGHT (OD) EYE BUT THERE ARE NO CELL, FLARE, OR KERATIC PRECIPITATES OR SYNECHIAE AT VISIT. ECP RECOMMENDED REDUCTION IN LENS USE AND PRESCRIBED FLOUROMETHOLONE TWICE DAILY FOR 2 WEEKS. AS OF THE DATE OF LAST MEDICAL INFORMATION RECEIVED AND DATE OF THIS REPORT, THE INCIDENT REMAINS UNRESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321227 CLARITI 1 DAY TORIC (SOMOFILCON A) CLARITI 1 DAY TORIC (SOMOFILCON A) MVN COOPERVISION CL KFT Y0117611

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Female Other