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

Model Number	TFAT00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Impairment (2138); Visual Disturbances (2140)
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility representative reported that following intraocular lens (iol) implant procedure, patient had glare.The lens was exchanged for an unknown advanced technology intraocular lens (atiol), 1 year and 7 months after the initial implant procedure.The clinical reason was unsatisfaction with vision and glare.Additional information has been requested.
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
Corrected information was provided in d.4.Additional information provided d,10.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The product was not returned.A device history record review and a non-conformance review of the reported lot number was conducted.The deviation review did not reveal any potential contributing factors to the reported complaint and all corresponding production release specifications defined in the device master record were met.The account indicated the use of a qualified cartridge, handpiece and viscoelastic.The product investigation could not identify a root cause for the reported complaint.Each lens is subjected to a 100 percent assessment of the power and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.Information was provided that the company multifocal, 21.5 diopter (add power +2.2/+3.2) lens was replaced with a non-company, 20.0 diopter, monofocal lens model.Due to the exchange of a multifocal lens to a 1.50 lower diopter, monofocal lens, this may suggest that the replacement lens model was an improved choice for the patient's vision needs.No additional information has been provided at this time.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been requested and received stating that consumer contacted company regarding issues with left eye since lens exchange.Patient states had five surgeries and unable to see clearly.Patient feels the wrong lens was originally implanted which caused the continuing problems.The lens was exchanged with non-company iol.

• Brand Name: ACRYSOF IQ PANOPTIX UV ABSORBING 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; 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: 20358434
• Report Number: 1119421-2024-01946
• Device Sequence Number: 7199292
• Product Code: MFK
• UDI-Device Identifier: 00380652429740
• UDI-Public: (01)00380652429740(17)270417(11)220419(10)15386686(21)15386686035
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/08/2025

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: TFAT00
• Device Catalogue Number: TFAT00.215
• Device Lot Number: 15386686
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/04/2024
• Supplement Date Received by Manufacturer: 10/03/2024; 08/18/2025
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 10/29/2024; 09/08/2025
• Date Device Manufactured: 04/19/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: J&J AR40E 20.0 2295792415; REPLACEMENT LENS: UNSPECIFIED ATIOL
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male