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

Model Number	TFNT00
Medical Device Problem Code	Material Opacification (1426)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	03/12/2015
Type of Reportable Event	Malfunction
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 following the cataract surgery with intraocular lens (iol) implant procedure, the patient experienced blurred vision.The lens implant has opacified she sees 6/30 with difficulty and had seen 6/6 previously.Additional information has been requested however no further information received.
Additional Manufacturer Narrative
Additional information provided h.11.Associated products were not provided.It is unknown if qualified products were used.The product investigation could not identify a root cause for the reported "blurred vision" complaint.Each lens is subjected to a 100% assessment of the power and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.It was reported that the lens was implanted in (b)(6) 2015 and the patient's vision was good until (b)(6) 2024.Information was provided that the patient had previously developed renal failure following e-coli sepsis in 2018 and then was diagnosed with diabetes eight years ago.Additional information was provided the surgeon was planning to exchange the lens.No further information has been provided at this time.Due diligence has been performed in an attempt to obtain further information on this event.The product has not been received to evaluate.File will be reopened if new information or the sample is received.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: 22084948
• Report Number: 1119421-2025-01494
• Device Sequence Number: 6925937
• Product Code: MFK
• UDI-Device Identifier: 00380652357791
• UDI-Public: (01)00380652357791(17)200930(11)151023(10)12409138
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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): 08/05/2025

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: 09/30/2020
• Device Model Number: TFNT00
• Device Catalogue Number: TFNT00.230
• Device Lot Number: 12409138
• 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: 04/30/2025
• Supplement Date Received by Manufacturer: 07/11/2025
• Initial Report FDA Received Date: 05/26/2025
• Supplement Report FDA Received Date: 08/05/2025
• Date Device Manufactured: 10/23/2015
• 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 Age: 59 YR
• Patient Sex: Female