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
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 received and stated that, the day after first surgery on (b)(6) 2022, noticed vision was still blurry and there was a white fog, patient stated like looking through.In all there was no improvement to vision, with glare from lights, foggy and blurry vision.The patient stated after surgery vision was worse than before surgery.The patient stated he has gone for a 1 day, 1 week, 3 month and 6 month follow ups, and constantly told them of problems.The patient was given different eye drops, which did not help and been told everything was fine.The follow ups were not done by surgeon who performed the surgery but another physician in the practice.On (b)(6) 2023 initial surgeon performed lasik which made a small amount of improvements.Patient still have white fog coming and going.The patient need reading glasses again for newspaper and other small print and this strange distortion and blurry vision at all distances.The patient like to play golf but need someone to watch where my ball goes.On (b)(6) 2023, the patient consulted with a retina specialist who couldn't offer anything to help.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
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.(b)(6) 2024 the patient was seen at hospital.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).
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 received and stated that, the day after first surgery on (b)(6) 2022, noticed vision was still blurry and there was a white fog patient stated like looking through.In all there was no improvement to vision, with glare from lights, foggy and blurry vision.After second surgery on (b)(6) 2022 vision became worse with continued white fog areas coming and going, glare from lights, a since of distortion, blurriness and a feeling eyes were straining to focus.The patient stated after surgery vision was worse than before surgery.The patient stated he has gone for a 1 day, 1 week, 3 month and 6 month follow ups, and constantly told them of problems.The patient was given different eye drops, which did not help, and told everything was fine.The follow ups were not done by surgeon who performed the surgery but another physician in the practice.On (b)(6) 2023 initial surgeon performed lasik which made a small amount of improvements.I still have white fog coming and going.The patient need reading glasses again for newspaper and other small print and this strange distortion and blurry vision at all distances.The patient like to play golf, but need someone to watch where my ball goes.On (b)(6) 2023, the patient consulted with a retina specialist who couldn't offer anything to help.There are two medical device reports associated with this patient.This report is associated with the right eye.

• 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: 21196543
• Report Number: 1119421-2025-00206
• Device Sequence Number: 18253472
• Product Code: MFK
• UDI-Device Identifier: 00380652414975
• UDI-Public: (01)00380652414975(17)241130(11)191209(10)12764163
• 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): 04/02/2025

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: 11/30/2024
• Device Model Number: TFNT00
• Device Catalogue Number: TFNT00U190
• Device Lot Number: 12764163
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/29/2024
• Supplement Date Received by Manufacturer: 03/05/2025
• Initial Report FDA Received Date: 01/21/2025
• Supplement Report FDA Received Date: 04/02/2025
• Date Device Manufactured: 12/09/2019
• 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: Male