BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYDAY TORIC (STENFILCON A)

    MDR report key: 18322766 · Received December 13, 2023

    Report

    Report Number
    2640128-2023-00015
    Event Type
    Injury
    Date Received
    December 13, 2023
    Report Date
    December 13, 2023
    Manufacturer
    COOPERVISION MANUFACTURING PUERTO RICO, LLC
    Product Code
    LPL
    PMA / PMN Number
    K131378
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SEE (H3) NO DEVICE SAMPLE WAS RETURNED FOR MANUFACTURER ANALYSIS. INVESTIGATION OF THE PROVIDED LOT NUMBER FOUND NO ISSUES OR NON-CONFORMANCE'S AND NO TRENDS WERE IDENTIFIED. NO ROOT CAUSE COULD BE ESTABLISHED. THE RELATIONSHIP BETWEEN THE COOPERVISION DEVICE AND THE EVENT IS UNCONFIRMED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED AS APPROPRIATED.

    Description of Event or Problem · 0

    INFORMATION RECEIVED FROM THE PURCHASE LOCATION, AS PROVIDED BY THE PATIENT, INDICATES THAT WHILE THE PATIENT RESIDES IN THE UK, THE INCIDENT FIRST OCCURRED AND PATIENT WAS FIRST SEEN FOR TREATMENT IN BULGARIA. IT IS REPORTED THE PATIENT EXPERIENCED AN INFECTIOUS CORNEAL ULCER OF THE LEFT (OS) EYE THAT COULD NOT BE CONTROLLED WITH TREATMENT THAT RESULTED IN VISION LOSS AND SUBSEQUENT SURGICAL EVISCERATION AND IMPLANT PLACEMENT IN THE LEFT EYE. NO DIAGNOSIS OR MEDICAL TREATMENT RECORDS HAVE BEEN PROVIDED, HOWEVER, MEDICATION PRESCRIPTION CARDS FROM BULGARIAN TREATMENT PROVIDED AND INDICATES THE PATIENT WAS PRESCRIBED VARIOUS MEDICATIONS ON 31 AUGUST, 01 SEPTEMBER, 03 SEPTEMBER, 04 SEPTEMBER THAT INCLUDE FLUOROURACIL, ATROPINE, COLLARGOL, CYCLOSPORIN, FLUCONAZOLE, GLUCOSA, SODIUM CROMOGLYCATE, SULFACETAMIDE, TACROLIMUS, VANCOMYCIN, VITAMIN A, VORICONAZOLE, AND ACYCLOVIR. MINIMAL INFORMATION ON MEDICAL TREATMENTS OR INTERVENTIONS IS BETWEEN 04 SEPTEMBER AND 22 SEPTEMBER. IT IS NOTED THAT ON 16 SEPTEMBER PATIENT HAD RETURNED TO UK (SPECIFIC DATE NOT PROVIDED) AND WAS SEEN WITH A HISTORY OF INFECTIVE CORNEAL ULCER THAT WAS PERFORATED AT ROYAL SHREWSBURY HOSPITAL. HOSPITAL NOTES FROM 22 SEPTEMBER AT ROYAL SHREWSBURY EYE CASUALTY INDICATED A PERFORATED CORNEAL ULCER, SIGNIFICANT PERIORBITAL CELLULITIS WITH LID EDEMA, AND LARGE KERATITIS/CORNEAL ABSCESS WITH THICK HYPOPYON. CONJUNCTIVAL SWAB PREVIOUSLY TAKEN POSITIVE FOR CORYNEBACTERIUM AMYCOLATUM. PATIENT IS TO CONTINUE ON PREVIOUSLY PRESCRIBED LEVOFLOXACIN AND CEFUROXIME HOURLY AND PRESCRIBED AUGMENTIN FOR 1 WEEK. PATIENT HAD ADDITIONAL APPOINTMENTS ON 23 AND 25 SEPTEMBER, NO DETAILS PROVIDED. MEDICAL RECORD DATED 29 SEPTEMBER INDICATES PATIENT UNDERWENT PENETRATING KERATOPLASTY, SUBCONJUNCTIVAL INJECTION, BIOPSY OF LESION AND TECTONIC GRAFT PLACEMENT COMPLETED 28 SEPTEMBER, CURRENT EYE MEDICATIONS INCLUDE DEXAMETHASONE DROPS FOUR TIMES DAILY, OFTAQUIX DROPS SIX TIMES DAILY, CEFUROXIME DROPS SIX TIMES DAILY AND ORAL AUGMENTIN TO BE CONTINUED. FOLLOW-UP SCHEDULED FOR ONE WEEK. ON 05 OCTOBER PATIENT SEEN AT ROYAL SHREWSBURY ONE WEEK AFTER SURGERY, GRAFT IS CLEAR AND AC WELL FORMED, NO SIGNS OF INFECTION. ALL DROPS TO BE CONTINUED BUT REDUCED TO FOUR TIMES DAILY, ACULAR DROPS PRESCRIBED THREE TIMES DAILY, PATIENT TO RETURN 10 OCTOBER. ON 06 OCTOBER PATIENT WAS SEEN IN EYE CASUALTY AT ROYAL SHREWSBURY FOR SUDDEN ONSET OF EYE PAIN AND LED EDEMA, GRAFT WAS CLEAR AND BANDAGE CONTACT LENS IN PLACE, A FEW DESCEMET FOLDS NOTED AT THE GRAFT. PATIENT WAS STARTED ON ORAL CA-OMAXACLAV FOR ONE WEEK AND INSTRUCTED TO KEEP FOLLOW-UP APPOINTMENT SCHEDULED FOR 10 OCTOBER. NO MEDICAL INFORMATION PROVIDED FOR TREATMENT OR STATUS BETWEEN 06 OCTOBER AND 28 NOVEMBER. ON 28 NOVEMBER PATIENT WAS SEEN AT ROYAL SHREWSBURY WHERE SURGICAL LEFT EYE EVISCERATION AND IMPLANT PLACEMENT WITH TEMPORARY SUTURE TARSORRHAPHY. PATIENT WAS DISCHARGED WITH CO-AMOXICLAV TABLETS THREE TIMES DAILY, IBUPROFEN THREE TIMES DAILY, CO-CODOMOL FOUR TIMES DAILY. RECORDS INDICATE THE SURGERY WAS PERFORMED WITHOUT COMPLICATION AND PATIENT WAS DISCHARGED THE SAME DAY, PATIENT IS SCHEDULED FOR FOLLOW-UP ON 05 DECEMBER 2023. NO FURTHER INFORMATION HAS BEEN RECEIVED TO DATE. THIS EVENT IS BEING REPORTED DUE TO THE INDICATION OF INFECTIOUS CORNEAL ULCER THAT RESULTED IN PERMANENT IMPAIRMENT OF THE EYE FUNCTION AND STRUCTURE. SHOULD FURTHER INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED AS APPROPRIATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328021 MYDAY TORIC (STENFILCON A) MYDAY TORIC (STENFILCON A) LPL COOPERVISION MANUFACTURING PUERTO RICO, LLC 9761500609

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Unknown Other| S