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

Model Number	TFNT30
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	04/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A non-healthcare professional reported that following an intraocular lens (iol) implant procedure, the patient experienced hyperopic shift.Additional information was received and stated, the lens was not replaced but in 2024 autumn patient got 1st add on pseudophakic lens in the left eye.The surgeon explained to patient that when they cover the right eye (unoperated eye) the vision will be quantifiably okay.The right eye was now not operated; the surgery was scheduled for end of (b)(6) 2025 for company lens.The surgeon expects that if both eyes had diffractive technology lens, the neuroadaptation would help the patient.Since it looks like now that the od is somehow disturbs the patient to get used to the iol.Additional information was received and stated, add on pseudophakic lens was not an company product.
Additional Manufacturer Narrative
The product was not returned.Product history records were reviewed and documentation indicated the product met release criteria.Associated products were not provided.The product investigation could not identify a root cause for the reported complaint.The lens remains implanted.Each lens is subjected to a 100 percent assessment of the power (spherical and cylinder) and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.It is unclear if the issue occurred over time or at initial implant.Information was provided that the lens was implanted in (b)(6) 2022.A piggyback lens was implanted (b)(6) 2024 with ucva 0.9.Patient unhappy with binocular vision.The patient is having bilateral implant the end of april.The surgeon expects hopes this will help the patient with adaption.The file will be reopened if new information is received.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: 21936568
• Report Number: 1119421-2025-01249
• Device Sequence Number: 5355987
• Product Code: MFK
• UDI-Device Identifier: 00380652390019
• UDI-Public: (01)00380652390019(17)260511(11)210513(10)15197878
• Combination Product (Y/N): N
• Initial Reporter Country: HU
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/30/2025

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: 05/11/2026
• Device Model Number: TFNT30
• Device Catalogue Number: TFNT30.220
• Device Lot Number: 15197878
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/02/2025
• Initial Report FDA Received Date: 04/30/2025
• Date Device Manufactured: 05/13/2021
• 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: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Unknown