Description of Event or Problem · 0
I AM A LONG-TERM SCLERAL LENS WEARER (OVER 14 YEARS), PREVIOUSLY USING STANDARD SCLERAL LENSES AND, MORE RECENTLY, CUSTOM EYEPRINTPRO LENSES FITTED IN (B)(6) 2024. FOR OVER 5 YEARS, I USED SCLERALFIL PRESERVATIVE-FREE SALINE SOLUTION TO FILL MY SCLERAL LENSES DAILY, WITH NO COMPLICATIONS. IN (B)(6) 2024, AFTER RUNNING OUT OF SCLERALFIL, I BEGAN USING NUTRIFILL PRESERVATIVE-FREE SALINE SOLUTION, WHICH I HAD PRE-PURCHASED IN ADVANCE. THE LOTS I USED WERE: HKF, HKK, AND HGC -- WHICH WERE OFFICIALLY INCLUDED IN A CONTAMAC URGENT: MEDICAL DEVICE RECALL COMMUNICATED TO ME (B)(6). SHORTLY AFTER STARTING NUTRIFILL (WITHIN DAYS TO A WEEK), I BEGAN EXPERIENCING FOGGING, DISCOMFORT, AND A RAPID DECLINE IN VISUAL CLARITY IN MY LEFT EYE, WHICH HAS A PRIOR CORNEAL TRANSPLANT (OVER 10 YEARS AGO). THERE WERE NO OTHER CHANGES TO MY LENS CARE ROUTINE OR OCULAR HEALTH HISTORY ASIDE FROM THE SWITCH TO NUTRIFILL. ON (B)(6) 2024, I HAD A SUDDEN AND SIGNIFICANT WORSENING OF SYMPTOMS. I WAS SEEN IN THE EMERGENCY DEPARTMENT, WHERE I WAS DIAGNOSED WITH A SEVERE CORNEAL INFECTION. CULTURES CONFIRMED PSEUDOMONAS AERUGINOSA AND STAPHYLOCOCCUS CAPITIS. I WAS TREATED UNDER THE CARE OF A CORNEA SPECIALIST WITH AGGRESSIVE TOPICAL ANTIBIOTIC THERAPY INCLUDING FORTIFIED TOBRAMYCIN, ERYTHROMYCIN, VORICONAZOLE, AND MOXIFLOXACIN. BY LATE (B)(6) 2024, THE INFECTION WAS CONTROLLED, BUT IT LEFT BEHIND A DENSE STROMAL SCAR ACROSS THE TRANSPLANTED CORNEA, REDUCING VISION AND AFFECTING MY ABILITY TO WEAR SCLERAL LENSES COMFORTABLY. SINCE THEN, I'VE BEEN USING PREDNISOLONE AND LOSARTAN DROPS TO CONTROL INFLAMMATION AND MANAGE CORNEAL SCARRING. ATTEMPTS TO RESUME SCLERAL LENS WEAR HAVE BEEN LIMITED BY INCREASED OPACITY AND CLOUDING DURING WEAR. VISION WORSENS WITHIN 4?8 HOURS OF LENS USE, EVEN AFTER PROPER LENS CLEANING AND REINSERTION. HOWEVER, WHEN DISCONTINUING LENS WEAR ENTIRELY FOR 48 HOURS, VISION CLARITY PARTIALLY RETURNS, THOUGH THE SCAR REMAINS. THIS PATTERN HAS PERSISTED AND SIGNIFICANTLY IMPACTS MY QUALITY OF LIFE. I AM SUBMITTING THIS MEDWATCH REPORT BECAUSE I BELIEVE THE NUTRIFILL SOLUTION -- FROM THE NOW-RECALLED LOTS HKF, HKK, AND HGC -- MAY HAVE CONTRIBUTED TO THE CORNEAL INFECTION. THESE PRODUCTS WERE THE ONLY MAJOR CHANGE IN MY LENS ROUTINE BEFORE THE INFECTION ONSET, AND THE TIMING OF SYMPTOMS CLOSELY ALIGNS WITH THEIR USE. I WAS UNAWARE OF ANY CONTAMINATION OR RECALL UNTIL THE OFFICIAL ANNOUNCEMENT IN (B)(6) 2025. GIVEN THE SEVERITY OF THE INFECTION AND THE LASTING IMPACT TO MY VISION, I BELIEVE THIS ADVERSE EVENT SHOULD BE DOCUMENTED IN CONNECTION WITH THE CONTAMINATED PRODUCT LOTS. REFERENCE REPORTS: MW5170642 AND MW5170643.