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

Model Number	TFNT00
Medical Device Problem Codes	Material Opacification (1426); Particulates (1451)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	05/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A healthcare professional reported that a patient who had an intraocular lens (iol) implanted approximately nine years ago recently returned for a postoperative evaluation.During this visit, opacification of the lens was observed.The opacification could not be resolved using yag laser treatment, suggesting the presence of foreign material or degradation of the lens itself.
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
Corrected information provided in h.6.And h.11 fda patient code of (b)(6) should not have been reported on initial mdr submitted.Additional information was provided in b.5.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was received about a patient who had an iol implanted in 2016.During the post-op check, opacification on the lens was seen, which could not be removed by yag-laser.Foreign material was identified during the 9-year post-operative review.The patient¿s vision was impacted due to this opacification.Additional information has been requested however no further information available.

• 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: 22318440
• Report Number: 1119421-2025-01745
• Device Sequence Number: 8830455
• Product Code: MFK
• UDI-Device Identifier: 00380652357753
• UDI-Public: (01)00380652357753(17)210131(11)160215(10)12430885
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: TFNT00
• Device Catalogue Number: TFNT00.210
• Device Lot Number: 12430885
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/25/2025
• Supplement Date Received by Manufacturer: 07/29/2025
• Initial Report FDA Received Date: 06/24/2025
• Supplement Report FDA Received Date: 08/22/2025
• Date Device Manufactured: 02/15/2016
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown