MAUDE Adverse Event Report: ASEPT PAK NUTRIFILL

Lot Number	HFH
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Microbial Contamination of Device (2303)
Health Effect - Clinical Codes	Red Eye(s) (2038); Eye Infections (4466); Eye Pain (4467)
Date of Event	09/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Although patient used several products and initial investigation of nutrifill has shown no abnormalities, patient indicated that one vial would last for 2-3 days of application/wear.Saving and reusing a single-use preservative free ampoule could introduce bacteria into the contact lens wearing environment and cause infection.Single-use ampoules are meant to be discarded immediately after use as instructed on packaging.It is possible that patient misuse introduced infection.
Event or Problem Description
Patient (b)(6) contacted the company on 11/13/2024 indicating they had recently been treated for several infections.On 11/14 (b)(6) agreed to a phone call to describe the event(s).(b)(6) began wearing scleral lenses for keratoconus in (b)(6) of 2024 (post corneal transplant).(b)(6) used uniqueph disinfecting solution, nutrifill saline solution for filling their scleral lenses, and systane pf drops and an unknown saline to occasionally rinse lenses.(b)(6) indicated that they would use one vial of nutrifill for 2-3 days.Sometime in august (b)(6) began to experience irritation, redness and pain ou when wearing lenses.By the end of august (b)(6) visted their ophthamologist for an emergency visit.(b)(6) was advised they had an infection from their contact lenses and were prescribed moxyfloxacin and told to discontinue wear for 10 days until symptoms resolved.(b)(6) resumed wear after the advised time period and immediately the symptoms resumed and the opththamologist again adviced to discontinue contact lens wear, prescribed moxyfloxacin and reviewed disinfection of contact lenses and to replace their contact lens case and suggested using clearcare to disinfect lenses.After sseing their optometrist (b)(6) resumed contact lens wear using lacripure for their filling solution and using clearcare once a week to disinfect and has not had any issues since.(b)(6) then contacted contamac solutions and provided information about the adverse event and shared that they had been using lot number hfh (purchased in july 2024) and sent 4 unopened vials and 2 vials that had been open in a zip-loc bag for testing.
Additional Manufacturer Narrative
Although patient used several products and initial investigation of nutrifill has shown no abnormalities, patient indicated that one vial would last for 2-3 days of application/wear.Saving and reusing a single-use preservative free ampoule could introduce bacteria into the contact lens wearing environment and cause infection.Single-use ampoules are meant to be discarded immediately after use as instructed on packaging.It is possible that patient misuse introduced infection.Update: information received later from the manufacturer, including the retesting of 4 different sets of samples (retained samples and samples collected from the field) has indicated 2 sets of samples were non-sterile.Misuse could have contributed to the symptoms, but we now are unable to confirm the sterility of lot hfh.This lot is being recalled.
Event or Problem Description
Patient (b)(6) contacted the company on (b)(6) 2024 indicating they had recently been treated for several infections.On (b)(6) agreed to a phone call to describe the event(s).(b)(6) began wearing scleral lenses for keratoconus in (b)(6) 2024 (post corneal transplant).(b)(6) used uniqueph disinfecting solution, nutrifill saline solution for filling their scleral lenses, and systane pf drops and an unknown saline to occasionally rinse lenses.(b)(6) indicated that they would use one vial of nutrifill for 2-3 days.Sometime in (b)(6) began to experience irritation, redness and pain ou when wearing lenses.By the end of (b)(6) visted their ophthamologist for an emergency visit.(b)(6) was advised they had an infection from their contact lenses and were prescribed moxyfloxacin and told to discontinue wear for 10 days until symptoms resolved.(b)(6) resumed wear after the advised time period and immediately the symptoms resumed and the opththamologist again adviced to discontinue contact lens wear, prescribed moxyfloxacin and reviewed disinfection of contact lenses and to replace their contact lens case and suggested using clearcare to disinfect lenses.After sseing their optometrist (b)(6) resumed contact lens wear using lacripure for their filling solution and using clearcare once a week to disinfect and has not had any issues since.(b)(6) then contacted contamac solutions and provided information about the adverse event and shared that they had been using lot number hfh (purchased in (b)(6) 2024) and sent 4 unopened vials and 2 vials that had been open in a zip-loc bag for testing.

• Brand Name: NUTRIFILL
• Common Device Name: NUTRIFILL
• Manufacturer (Section D): ASEPT PAK; 64 west st; malone NY 12953
• Manufacturer (Section G): ASEPT PAK; 64 west st; malone NY 12953
• Manufacturer Contact: jessica labriola ; 806 kimball ave; grand junction, CO 81501 ; 9709854240
• MDR Report Key: 20994863
• Report Number: 3016114779-2024-00012
• Device Sequence Number: 9867546
• Product Code: MRC
• UDI-Device Identifier: 00850012123002
• UDI-Public: 00850012123002
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K181566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/28/2026
• Device Lot Number: HFH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2024
• Supplement Date Received by Manufacturer: 11/14/2024
• Initial Report FDA Received Date: 12/20/2024
• Supplement Report FDA Received Date: 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 96900
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SCLERAL LENS (UNKNOWN).; SCLERAL LENS (UNKNOWN).; SYSTANE PF.; SYSTANE PF.; UNIQUEPH.; UNIQUEPH.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female