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); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Posterior Capsule Opacification (4807)
Type of Reportable Event	Serious Injury
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).
Event or Problem Description
A health care professional reported that following an intraocular lens (iol) implant procedure, posterior capsule opacification, calcified lens.Laser yag assessment showed trace pco, lens appeared calcified.Additional information was received stating elschnigs pearl formation in the periphery.Excimer laser enhancement has received with very good outcome.Subsequently, he was discharged there are two medical device reports associated with this patient.This report is associated with the left eye.
Additional Manufacturer Narrative
Correction information was provided in h.6.Eval method codes (b17) has been updated to (b20).Additional information was provided in section b.5., and h.11.Fda product codes(a0409) has been updated to (a24).The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was received stating based on recent visit of patient surgeon stated lens was not opacified and has recommended to proceed with yag.
Additional Manufacturer Narrative
Correction information was provided in b.2 and h.11.Upon further review of the reported information, following submission of the initial report, this event posterior capsule opacification (elschnigs pearl formation in the periphery) does not meet criteria for reporting as a serious injury.No further reports required.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: 22661396
• Report Number: 1119421-2025-02089
• Device Sequence Number: 7449309
• Product Code: MFK
• UDI-Device Identifier: 00380652357814
• UDI-Public: (01)00380652357814(17)230731(11)180806(10)12637130
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/28/2025

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: 07/31/2023
• Device Model Number: TFNT00
• Device Catalogue Number: TFNT00.240
• Device Lot Number: 12637130
• 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: 07/04/2025
• Supplement Date Received by Manufacturer: 09/01/2025; 11/06/2025
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 09/26/2025; 11/28/2025
• Date Device Manufactured: 08/06/2018
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Unknown