MENICON Z RIGID GAS PERMEABLE LENS
Received Dec 26, 2012 · Event occurred Nov 28, 2012
Report 9614761-2012-00002 · MDR key 2890996
Device
Generic name
Rgp Contact Lens
Manufacturer
Menicon Co. Ltd.Product problems
- Insufficient Device Problem Information
Patient
59 YR
- Corneal Ulcer
- Pain
Narrative
Description of Event or Problem
THE INFO WAS RECEIVED FROM SAFETY ADMINISTRATION SECTION OF MENICON IN (B)(4). A PATIENT HAD PAIN IN RIGHT EYE. SHE WAS SEEN BY HER OPHTHALMOLOGIST AND DIAGNOSED AS CORNEAL ULCER. THEN, SHE WAS REFERRED TO A HOSPITAL FOR ADMISSION. SHE WAS TREATED WITH ERYTHROMYCIN, HYALURONIC ACID, FLAVIN ADENINE DINUCLEOTIDE (FAD) AND TARIVID (OFLOXACIN) OINTMENT AND INTRAVENOUS DRIP TRANSFUSION. THE TOTAL TREATMENT TIME WAS FOR 15 DAYS AND THE PATIENT WAS DISCHARGED ON (B)(6). SHE HAS RETURNED TO NORMAL CONDITION AND HER VISUAL ACUITY HAS RECOVERED TO 0.9 AT THE TIME OF DISCHARGE. NO ADD¿L INFO AVAILABLE.