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

Model Number	TFNT00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Vitreous Floaters (1866); Blurred Vision (2137); Visual Impairment (2138); Visual Disturbances (2140)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A consumer reported that following an intraocular lens (iol) implant procedure, patient experienced blurred distance vision, cloudiness, floaters, and light glare impacting life.Patient undergone lasik surgery to correct distance vision.After surgery patient intermediate vision improved distance vision is not improved.Additional information was requested and received stated patient symptoms are still continuing.There are two medical device reports associated with this patient.This report is associated with the left eye.
Event or Problem Description
Additional information was requested and received symptoms are still continuing and also reported that need glasses to read news paper and small prints, patient experiencing blurry vision at all distances.
Additional Manufacturer Narrative
The product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.Associated product information was not provided.The product investigation could not identify a root cause for the reported vision complaint.The product remained in the eye.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.The patient is the reporter.Information was provided that the patient¿s vision issues began the day after the first surgery on (b)(6) 2022.A second surgery was performed on (b)(6) 2022 and visual issues became worse.Follow ups with a doctor were at day 1, week 1, month 3 and month 6.The consumer indicated that eye drops were given and assured the lenses were fine.These follow ups were with doctors in the same practice other than the implanting surgeon.The implanting surgeon ( for whom it was indicated does not conduct follow up appointments) conducted a follow up for this patient to assist with the issue.On (b)(6) 2023 lasik surgery was performed which made small amounts of improvements.Some visual issues still persist.A retina specialist was consulted on (b)(6) 2023 without positive outcome.O (b)(6) 2024 the patient was seen at (b)(6).After consulting with 3 different doctors there, the patient indicated that they will try contact lenses in (b)(6) 2025.File will be reopened if new information or the sample becomes available.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; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 21191160
• Report Number: 1119421-2025-00198
• Device Sequence Number: 8740365
• Product Code: MFK
• UDI-Device Identifier: 00380652357722
• UDI-Public: (01)00380652357722(17)260919(11)210921(10)15266612
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/19/2026
• Device Model Number: TFNT00
• Device Catalogue Number: TFNT00.195
• Device Lot Number: 15266612
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/29/2024
• Supplement Date Received by Manufacturer: 01/21/2025
• Initial Report FDA Received Date: 01/20/2025
• Supplement Report FDA Received Date: 02/18/2025
• Date Device Manufactured: 09/21/2021
• 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: Other; Required Intervention
• Patient Sex: Unknown