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

Model Number	TFNT40
Medical Device Problem Codes	Material Opacification (1426); Material Deformation (2976)
Health Effect - Clinical Code	Blurred Vision (2137)
Type of Reportable Event	Serious Injury
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).
Event or Problem Description
A health care professional reported that after an intraocular lens (iol) implant procedure, patient complaining of blurred vision 6 years post cataract and iol implantation.Additional information has been received and stated that patient experienced hazy iol, glistenings and the lens was planned to be explanted.
Event or Problem Description
Additional information has been received and stated that the lens was explanted and replaced with different model company lens.
Additional Manufacturer Narrative
Additional information was provided in b.2., b.5., d.6b., h.3., h.6.And h.11.The product was not returned.A batch 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 medical device file were met.The product investigation could not identify a root cause for the reported complaint.The product was not returned.Information indicated the lens had been implanted for six years.The company lens (2.25cyl), 19.5 diopter (add power +2.17/+3.25) lens was replaced with a company lens (2.25cyl), 19.5 diopter (add power +2.17/+3.25) lens.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ PANOPTIX TORIC 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: 25230719
• Report Number: 1119421-2026-01089
• Device Sequence Number: 5108873
• Product Code: MFK
• UDI-Device Identifier: 00380652390514
• UDI-Public: (01)00380652390514(17)231031(11)181129(10)12671286
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2026
• 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): 07/21/2026

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: 10/31/2023
• Device Model Number: TFNT40
• Device Catalogue Number: TFNT40.195
• Device Lot Number: 12671286
• 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: 04/29/2026
• Supplement Date Received by Manufacturer: 06/28/2026
• Initial Report FDA Received Date: 05/20/2026
• Supplement Report FDA Received Date: 07/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: UNKNOWN CARTRIDGE; UNKNOWN INJECTOR; UNKNOWN VISCOELASTIC
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male