MAUDE Adverse Event Report: AMSINO HEALTHCARE (USA) INC. TANGILE FILL; SCLERAL SALINE 5ML

Model Number	2490
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Eye Infections (4466); Tissue Irritation (4912)
Date of Event	07/31/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The end user returned (b)(4) of the (b)(4) vials from the case, which amsino received on 14-aug-2025.Initial finished-product testing for lot l095, included assay, usp <71> sterility, and usp <85> bacterial endotoxins testing.To obtain multi-laboratory confirmation, amsino submitted a subset of the returned complaint samples from l095 to a different laboratory for usp <71> sterility and usp <85> endotoxin testing.Usp <85> results were received on 22-oct-2025 and met specification; usp <71> results were received on 31-oct-2025 and were negative.In addition, retention samples from the same lot were tested using the same methods, and all results were within specification.
Event or Problem Description
The end user reported: i was a user of nutrifill until i got the recall notice.I disposed of all remaining nutrifill product as recommended.Unfortunately, i needed to replace my scleral solution right away and it would have taken too long for it to arrive from the tangible science website.I ordered it from amazon so that i could get it asap so i could continue wearing my sclerals (required for my vision).The first day i used tangible fill, my eyes were slightly irritated by the end of the day.I assumed this was just adjusting to the new product.By day 5, my eyes were infected (red, draining, and gunky).Follow up message from end user: i got some eye medication and the infection has cleared up.I started using a different product (brand) and have had no further issues.I have the remaining product if you need to have it returned.

• Brand Name: TANGILE FILL
• Common Device Name: SCLERAL SALINE 5ML
• Manufacturer (Section D): AMSINO HEALTHCARE (USA) INC.; 330 corporate woods pkwy; vernon hills IL 60061
• Manufacturer (Section G): AMSINO HEALTHCARE (USA) INC.; 330 corporate woods pkwy; vernon hills IL 60061
• Manufacturer Contact: esteban encarnacion ; 330 corporate woods pkwy; vernon hills, IL 60061 ; 8473831409
• MDR Report Key: 23493343
• Report Number: 1417519-2025-00012
• Device Sequence Number: 18385806
• Product Code: MRC
• UDI-Device Identifier: 00198168143803
• UDI-Public: 01001981681438031127013110L095
• Combination Product (Y/N): Y
• PMA/510(K) Number: K201069
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/23/2025

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 Model Number: 2490
• Device Lot Number: L095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/01/2025
• Initial Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (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: Other; Required Intervention
• Patient Sex: Unknown