Description of Event or Problem · 0
SUBJECT: FDA MEDWATCH REPORT ¿ NUTRIFILL RECALL (LOT # HGN) DEAR FDA, I AM SUBMITTING THIS REPORT IN RESPONSE TO THE VOLUNTARY RECALL OF NUTRIFILL CONTACT LENS INSERTION SOLUTION, MANUFACTURED BY CONTAMAC SOLUTIONS, INC. I AM IN POSSESSION OF PRODUCT FROM THE RECALLED LOT # HGN, WITH THE FOLLOWING DETAILS: PRODUCT NAME: NUTRIFILL UNIQUE DEVICE IDENTIFIER (UDI): (B)(4), LOT NUMBER: HGN, DISTRIBUTION DATES: (B)(6) 2024, EXPIRATION DATE: 03/31/2026; I PERSONALLY USED TWO FULL CARTONS FROM THIS LOT AND HAVE ONE UNUSED CARTON REMAINING. AFTER USE, I EXPERIENCED NOTICEABLE EYE DISCOMFORT, INCLUDING IRRITATION AND BLURRED VISION, WHICH I INITIALLY ATTRIBUTED TO MY PREEXISTING EYE CONDITION. HOWEVER, UPON LEARNING ABOUT THE RECALL AND ITS LINK TO NON-STERILE PRODUCT RISKS, I BECAME CONCERNED ABOUT POTENTIAL EXPOSURE TO CONTAMINATION. I HAVE ALREADY SUBMITTED DOCUMENTATION TO CONTAMAC SOLUTIONS FOR PRODUCT REIMBURSEMENT AND TO REPORT MY CONCERNS. I AM NOW FILING THIS WITH THE FDA TO ENSURE PROPER REPORTING AND OVERSIGHT. PLEASE FIND MY SUPPORTING DOCUMENTATION ATTACHED. THANK YOU FOR YOUR TIME AND ATTENTION TO THIS MATTER. SINCERELY, (B)(6). REFERENCE REPORT MW5170900.