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 they had an ulcer and an infection in their eyes and spent approximately 4 months recovering.(b)(6) indicated that after inserting their contact lenses, they notices their eyes getting red and irritated.As the day progressed, the redness and irritation grew worse leading them to remove their contact lenses and visit the emergency room with unbearable pain.(b)(6) indicated that the doctor said they had an eye infection coupled with a cut (abrasion) to their cornea.

• 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: 22327235
• Report Number: 3016114779-2025-00077
• Device Sequence Number: 8560880
• 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): 06/25/2025

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: 05/18/2025
• Initial Report FDA Received Date: 06/25/2025
• 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