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

Model Number	TFNT60
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	High Blood Pressure/ Hypertension (1908); Blurred Vision (2137); Visual Disturbances (2140); Dizziness (2194); Halo (2227); Depression (2361); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/05/2024
Type of Reportable Event	Serious Injury
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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
Event or Problem Description
A non-healthcare professional reported that following an intraocular lens (iol) implant procedure, the patient experienced terrible glare across the entire eye from sunlight, from artificial lighting, constant glare if sitting facing a window, side glare, and an unbearable halo effect.The patient developed depression, blood pressure and blood sugar levels were increased.Currently, all symptoms remain, and sometimes patient even felt dizzy.Patient vision was not clear at all, there was no sharpness.There are two medical device reports associated with this patient.This report is associated with the right eye.
Additional Manufacturer Narrative
The product was not returned.Product history records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause for the reported complaint.The lens remains implanted.Each lens is subjected to a 100% 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.The reporter was the patient.The reporter indicated that they did not have cataracts.The lenses were implanted for vision correction only.Per the instructions for use (ifu): the company intraocular lens is indicated for primary implantation in the capsular bag in the posterior chamber of the eye for the visual correction of aphakia and the reduction of residual refractive astigmatism, in adult patients in whom a cataractous lens has been removed.The lens mitigates the effects of presbyopia by providing improved intermediate and near visual acuity, while maintaining comparable distance visual acuity with a reduced need for eyeglasses, compared to a monofocal intraocular lens (iol).Due diligence has been performed in an attempt to obtain further information on this event.The reporter has not responded to requests for follow-up information.File will be reopened if new information or the sample is received.The manufacturer internal reference number is: (b)(4.H.10 reflects all related report numbers associated with this product event that have been submitted at this time.

• 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: 20238657
• Report Number: 1119421-2024-01829
• Device Sequence Number: 15681731
• Product Code: MFK
• UDI-Device Identifier: 00380652391399
• UDI-Public: (01)00380652391399(17)250806(11)200807(10)15088832
• Combination Product (Y/N): N
• Initial Reporter Country: UP
• 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,Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2024

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: 08/06/2025
• Device Model Number: TFNT60
• Device Catalogue Number: TFNT60.085
• Device Lot Number: 15088832
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/21/2024
• Supplement Date Received by Manufacturer: 10/14/2024
• Initial Report FDA Received Date: 09/17/2024
• Supplement Report FDA Received Date: 11/12/2024
• Date Device Manufactured: 08/07/2020
• 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
• Patient Age: 45 YR
• Patient Sex: Female