MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ PANOPTIX TRIFOCAL IOL; LENS, MULTIFOCAL

Model Number	TFNT00
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	10/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare professional reported that following an intraocular lens (iol) implant procedure, the patient experienced blurred vision in the right eye.Upon examination, the ophthalmologist found that the retina was normal.However, iol exhibited signs of glistening.
Additional Manufacturer Narrative
The product was not returned for analysis; the lens remains implanted.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The product was not returned.A photo was provided.Clinical information review was provided of the photo.The attached image was of a multifocal iol through a dilated eye.The iol showed what appeared to be moderate to significant glistening throughout the lens.On rare occasions glistening can have a negative impact on a patient's vision.A device history record review and a non-conformance review of the reported lot number was conducted.The deviation review did not reveal any potential contributing factors to the reported complaint and all corresponding production release specifications defined in the device master record were met.The product investigation could not identify a root cause for the reported complaint.The product was not returned.A clinical information review was provided of the photo.The attached image was of a multifocal iol through a dilated eye.The iol showed what appeared to be moderate to significant glistening throughout the lens.On rare occasions glistening can have a negative impact on a patient's vision.Information was provided that the lens was implanted march of 2021.No determination can be made for the cause of the patient's blurry vision which occurred in october of 2025.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ PANOPTIX TRIFOCAL IOL
• Common Device Name: LENS, MULTIFOCAL
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 246 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 246 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 23597919
• Report Number: 1119421-2025-02982
• Device Sequence Number: 9337454
• Product Code: MFK
• UDI-Device Identifier: 00380652357739
• UDI-Public: (01)00380652357739(17)231031(11)181129(10)12669707
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: TFNT00
• Device Catalogue Number: TFNT00.200
• Device Lot Number: 12669707
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/27/2025
• Supplement Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 11/19/2025
• Supplement Report FDA Received Date: 12/29/2025
• Date Device Manufactured: 11/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MONARCH III IOL, CARTRIDGE C.; MONARCH III IOL, INJECTOR.
• Patient Age: 72 YR
• Patient Sex: Male