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 Codes	Vitreous Floaters (1866); Visual Impairment (2138)
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported that following an intraocular lens (iol) implant procedure, patient experienced glistenings and feels like his vision was getting worse.There was some sort of haziness over the posterior aspect of the lens.The patient had yag (yttrium aluminum garnet) procedure and possibly vitrectomy for floaters.Additional information was received, in the surgeon prognosis overall ocular health was normal.The glistenings on the posterior surface of the intraocular lens (iol) seem to be limiting vision.There are two medical device reports associated with this patient.This report is associated with the right eye.
Additional Manufacturer Narrative
A product was not returned for analysis.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
Additional information was provided in h.3., h.6.And h.11.The product was not returned.An image of an intraocular lens (iol) was provided with a question of association with glistenings and a report of, ¿some sort of haziness over the posterior aspect of the lens¿.The ¿haziness¿ in the photo appears more confluent than the characteristic appearance of microvacuoles associated with glistenings, and the location would be throughout the bulk of the lens compared to the posterior aspect reported.A cause or association of this appearance with the complaint product was not able to be determined based on the images and further assessment would be necessary to accurately identify these findings and determine their significance in relation to the associated product investigation.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.Additional response provided to the reporter.From the description and the photos provided, while not exactly consistent, a consideration for what is being observed could be subsurface nanoglistenings (ssng).Background on the topic (again with the caveat this may not be the same issue) was provided, and expert opinion surgeon as mentioned would likely be a good option to obtain feedback for more clinical expertise.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: 23413679
• Report Number: 1119421-2025-02815
• Device Sequence Number: 8983460
• Product Code: MFK
• UDI-Device Identifier: 00380652416061
• UDI-Public: (01)00380652416061(17)230930(11)181026(10)12659582
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2025

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: TFNT40
• Device Catalogue Number: TFNT40U205
• Device Lot Number: 12659582
• 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: 10/04/2025
• Supplement Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 12/12/2025
• Date Device Manufactured: 10/26/2018
• 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 D; MONARCH III IOL INJECTOR; ORA SYSTEM WITH VERIFEYE MESSAGING; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE; UNSPECIFIED FORCEPS
• Patient Age: 75 YR
• Patient Sex: Male