Description of Event or Problem · 0
THIS EVENT OCCURRED IN JAPAN. THE PATIENT WORE MENICON 1DAY PREMIO TORIC (DAILY WEAR CONTACT LENS), WHICH IS A SIMILAR DEVICE OF MIRU 1DAY UPSIDE (MIDAFILCON A) (K193399). SITUATION: THE FOLLOWING INFORMATION IS NOT FROM HEALTH CARE PROFESSIONALS, BUT FROM THE PATIENT(PT). ON (B)(6)2024, PT COULD NOT WEAR CONTACT LENSES BECAUSE OF EYE PAIN. ON (B)(6)2024, PT VISITED MEDICAL FACILITY A FOR A WHITE SPOT ON HER CORNEA AND RECEIVED A REFERRAL TO MEDICAL FACILITY B DUE TO THE SEVERITY OF HER CONDITION AND AN INSTRUCTIONS TO STOP WEARING LENSES. ON (B)(6) 2024, PT VISITED MEDICAL FACILITY B AND WAS DIAGNOSED WITH CORNEAL ULCER, INSTRUCTED TO STOP WEARING LENSES, AND RECEIVED THE FOLLOWING MEDICATIONS (GENTAMICIN SULFATE OPHTHALMIC SOLUTION, SODIUM HYALURONATE OPHTHALMIC SOLUTION, BESTRON FOR OPHTHALMIC, GATIFLO OPHTHALMIC SOLUTION, AND TARIVID OPHTHALMIC OINTMENT). SHE VISITED MEDICAL FACILITY B DAILY UNTIL (B)(6)2024. PT ALSO RECEIVED EYE DROPS EVERY HOUR. AFTER (B)(6)2024, PT VISITED MEDICAL FACILITY B ONCE OR TWICE A WEEK AND WAS DIAGNOSED AS MUCH RECOVERED. AFTER (B)(6)2024, PT VISITED MEDICAL FACILITY A ONCE OR TWICE A WEEK. SEVERAL OF THE INITIAL FIVE MEDICATIONS WERE REDUCED AND FLUOROMETHOLONE OPHTHALMIC SOLUTION WAS ADDED. IN (B)(6)2024, PT VISITED MEDICAL FACILITY A AND WAS TOLD THAT THE CORNEA WOULD NOT BE SMOOTH ANY LONGER. EYE DROPS WERE DISCONTINUED, AND THE PT WAS SWITCHED TO REGULAR CHECKUPS EVERY 3 MONTHS THEREAFTER. WE SHALL CONTINUE TO MONITOR THE MARKET, AND IF MEDICAL FACILITIES REPORT THE OCCURRENCE OF SIMILAR EVENTS, WE SHALL AGAIN SUBMIT A MEDICAL DEVICE REPORTING AND TAKE CORRECTIVE ACTION AS NECESSARY.