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 Codes	Blurred Vision (2137); Posterior Capsule Opacification (4807)
Date of Event	11/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported that the patient underwent cataract surgery to left eye on (b)(6) 2019.Subsequently, a yag capsulotomy was performed in the left eye on (b)(6) 2022.In 2025 the patient went for the follow up and upon examination, it was observed that the intraocular lens in the left eye was diffusely studded with glistening across the entire optic surface.This was not localized to a few spots but involved the whole lens optic.As a result, the patient vision dropped by one line for both distance and near in the left eye.Additional information has been requested.There are two medical device reports associated with this patient.This file is for left eye (os).
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.Photos were provided.A clinical review was conducted for the provided photos.Two slit lamp images of an intraocular lens (iol) in a dilated eye were provided showing apparent diffuse refractile bodies as reported.While it is difficult to determine conclusively based on the photos, if the location is within the bulk of the iol, this could be consistent with microvacuoles associated with glistenings based on appearance.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.Photos were provided.A clinical review was conducted for the provided photos.Two slit lamp images of an iol in a dilated eye were provided showing apparent diffuse refractile bodies as reported.While it is difficult to determine conclusively based on the photos, if the location is within the bulk of the iol, this could be consistent with microvacuoles associated with glistenings based on appearance.Information on the reported topic was provided to the local account representative who visited with the customer and addressed the questions.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: 23278872
• Report Number: 1119421-2025-02679
• Device Sequence Number: 5470284
• Product Code: MFK
• UDI-Device Identifier: 00380652357852
• UDI-Public: (01)00380652357852(17)230930(11)181025(10)12660979
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2025

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: 09/30/2023
• Device Model Number: TFNT00
• Device Catalogue Number: TFNT00.260
• Device Lot Number: 12660979
• 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: 09/19/2025
• Supplement Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 12/17/2025
• Date Device Manufactured: 10/25/2018
• 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
• Patient Sex: Female