MAUDE Adverse Event Report: ASEPT PAK NUTRIFILL

Lot Number	HGI
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Codes	Red Eye(s) (2038); Eye Infections (4466); Eye Pain (4467)
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient (b)(6) indicated that on (b)(6) 2024, their eyes would start feeling gritty and red after 6 hours, eventually leading to eye pain.Lenses kept getting harder to wear for more than a few hours at a time, eventually getting extreme even without contact lenses.(b)(6) was given drops by doctor on (b)(6) and was advised to start wearing contact lenses again after a couple of weeks.(b)(6) indicated that they tried to wear contact lenses again and could only do so for 4 hours without extreme pain and redness.(b)(6) returned to the doctor and confirmed infections in both eyes, giving (b)(6) more drops.After a further couple of weeks, the infection cleared up.(b)(6) was advised to change out all drops for new bottles and try again but the infection returned within a couple of hours of wear.(b)(6) returned to the doctor and received drops with the doctor noting the beginnings of corneal tearing or scarring, however (b)(6) saw a different doctor a week later who did not observe this.By the end on (b)(6) 2024, (b)(6) was advised by the doctor to stop wearing contact lenses for the time being.

• 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: 22307583
• Report Number: 3016114779-2025-00031
• Device Sequence Number: 18163209
• 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
• Report Date (Section B): 06/23/2025

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: 03/31/2026
• Device Lot Number: HGI
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2025
• Initial Report FDA Received Date: 06/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2024
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female