Description of Event or Problem · 0
I WAS DIAGNOSED WITH CONJUNCTIVITIS ON (B)(6) 2024, BY MY NEW PCP. THIS WAS ONE OF MANY TIMES THAT I HAD EYE INFECTIONS OVER THE NEXT COUPLE MONTHS. I NOW KNOW DUE USAGE OF CONTAMINATED SINGLE USE AMPOULES OF NUTRIFILL (TRADEMARK) STERILE BUFFER FLUID BY CONTAMAC SOLUTIONS, INC. I WAS NOTIFIED VIA EMAIL ON MAY 15, 2024, BY CONTAMAC SOLUTIONS, INC. OF AN URGENT: MEDICAL DEVICE RECALL NUTRIFILL, THAT NOTIFIED ME OF THE FOLLOWING; "DEAR (B)(6), PURPOSE OF THIS LETTER: CONTAMAC SOLUTIONS, INC. IS VOLUNTARILY RECALLING LOTS HFH, HGC, HGI, HGN, HKF, HKK OF NUTRIFILL, A PRESERVATIVE FREE CONTACT LENS INSERTION SOLUTION BECAUSE PRODUCTS MAY NOT BE STERILE. YOU ARE RECEIVING THIS NOTIFICATION BECAUSE YOU MAY HAVE RECEIVED NUTRIFILL PRODUCTS FROM ONE OR MORE OF THESE LOTS. SERIOUS INJURIES MAY HAVE OR COULD OCCUR DUE TO NON-STERILE PRODUCTS. FROM SEVEN COMPLAINTS, WE HAVE RECEIVED REPORTS OF TWENTY-THREE SERIOUS INJURIES THAT THE RECALLED PRODUCT MAY HAVE CONTRIBUTED TO; INJURIES RANGING FROM REDNESS, BURNING, AND IRRITATION TO INFECTIONS THAT SOMETIMES RESULTED IN THE DEVELOPMENT OF CORNEAL ULCERS HAVE BEEN REPORTED. PLEASE REVIEW THE INFORMATION IN THIS NOTIFICATION AND FOLLOW THE INSTRUCTIONS PROVIDED. THE RECALL IS BEING MADE WITH THE KNOWLEDGE OF THE UNITED STATES FOOD AND DRUG ADMINISTRATION" I AM DIAGNOSED WITH KERATOCONUS WHICH MAKES IT NECESSARY TO WEAR SCLERAL TYPE HARD CONTACT LENSES. THESE REQUIRE A BUFFER FLUID TO RIDE ON MY CORNEA. I BELIEVE I RECEIVED LOT HGC, LISTED ABOVE, FROM NUTRIFILL, ON (B)(6) 2024. I RECEIVED LOT HKK, LISTED ABOVE, FROM NUTRIFILL, ON (B)(6) 2024. I HAD MULTIPLE INFECTIONS OVER MULTIPLE MONTHS, TO THE POINT I DISCONTINUED USING THE CONTACTS AND HAVE APPROXIMATELY 60% OF THE CONTAMINATED LOT HKK LEFT. PRODUCT INFORMATION. PRODUCT DISTRIBUTION INFORMATION: PRODUCT NAME: NUTRIFILL UNIQUE DEVICE IDENTIFIER (UDI): (B)(4) LOT NUMBER: HGC DISTRIBUTION DATES: JULY 9, 2024 TO JULY 24, 2024, EXPIRATION DATE : 03/31/2026, QUANTITY: (B)(4), AMPOULES PRODUCT DISTRIBUTION INFORMATION: PRODUCT NAME: NUTRIFILL, UNIQUE DEVICE IDENTIFIER (UDI): (B)(4), LOT NUMBER: HKK, DISTRIBUTION DATES: SEPTEMBER 27, 2024 TO OCTOBER 18, 2024, EXPIRATION DATE 07/31/2026, QUANTITY: (B)(4) AMPOULES. REF REPORT: MW5171788.