Description of Event or Problem · 1
AN EYE CARE PROFESSIONAL (ECP) CONTACTED VISTAKON IN 2008 STATING THAT SHE TRIAL FIT A PT IN ACUVUE OASYS FOR ASTIGMATISM CONTACT LENSES (CL) ON ELEVEN DAYS EARLIER. THE WEAR SCHEDULE AND TYPE OF DISINFECTING SOLUTION ARE UNKNOWN. THE ECP STATED THAT THE PT REPORTED EXPERIENCING OS IRRITATION ON A WEEK PRIOR TO ORIGINAL DATE, AT WHICH TIME THE CL WAS REMOVED AND DISCARDED. ON THE NEXT DAY, THE PT AWAKENED AND RUBBED THE OS. THE EYE BECAME "EXTREMELY PAINFUL". THE PT PRESENTED TO THE ECP'S OFFICE COMPLAINING OF BLURRY VISION, PAIN, AND REDNESS AND LIGHT SENSITIVITY OS. THE ECP USED AKTAINE TO ASSESS THE PT'S VISION AND EYE STRUCTURES. THE EXAM REVEALED CIRCULAR CORNEAL EROSION OS OUTSIDE OF THE VISUAL AREA. THE PT WAS DIAGNOSED WITH SPK AND SUB-EPITHELIAL EDEMA. THE TREATMENT REGIMEN INCLUDED VIGAMOX TID AND ACULAR EVERY 4 HOURS AS NEEDED FOR PAIN. A BANDAGE LENS WAS PLACED ON THE PT'S OS. ON TWO DAYS LATER, THE PT RETURNED TO THE CLINIC WITH LIGHT SENSITIVITY, INCREASED COMFORT LEVEL AND FAINT SUB-EPITHELIAL EDEMA. THE PT WAS DX WITH MILD IRITIS, NO CELLS AND SMALL FLARE. ON THE NEXT DAY, THE ECP REMOVED THE BANDAGE LENS AND DISCONTINUED VIGAMOX. A LOT HISTORY REVIEW WAS NOT PERFORMED BECAUSE THE LOT NUMBERS WERE NOT PROVIDED. NO ADDITIONAL INFORMATION IS EXPECTED. MDR REPORTABLE EVENTS ARE REVIEWED IN QUARTERLY MANAGEMENT REVIEW MEETINGS.