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 Codes	Dry Eye(s) (1814); Blurred Vision (2137); Visual Disturbances (2140); Vitreous Detachment (2445); Posterior Capsule Opacification (4807)
Date of Event	05/15/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned for analysis; the lens remains implanted.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 healthcare professional reported that, after intraocular lens implantation surgery, the patient feels that she is seeing worse than before surgery, at all distances.The patient also experienced significant glare from traffic at night, in the form of halo effects (three rings around each lamp).The patient also developed posterior capsule opacification which was treated using yag capsulotomy.The surgeon stated that the patient's main issue was dry eye which was treated using the lubricating eye drops.The patient also had vitreous detachment around the macula.The patient was also treated with non steroidal anti-inflammatory drug.The symptoms were still continuing.Additional information has been received stating that, the lens remains implanted.There are two medical device reports associated with this patient.This report is associated with the left eye.

• Brand Name: ACRYSOF IQ PANOPTIX TORIC 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: 21512841
• Report Number: 1119421-2025-00576
• Device Sequence Number: 20834830
• Product Code: MFK
• UDI-Device Identifier: 00380652389921
• UDI-Public: (01)00380652389921(17)281219(11)231222(10)15773678
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/04/2025

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 Model Number: TFNT30
• Device Catalogue Number: TFNT30.175
• Device Lot Number: 15773678
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2025
• Initial Report FDA Received Date: 03/04/2025
• Date Device Manufactured: 12/22/2023
• 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: 49 YR
• Patient Sex: Female