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)
Date of Event	07/15/2025
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).
Event or Problem Description
A consumer (non-healthcare professional) reported that, following an intraocular lens (iol) implant procedure, blurry distance and near vision were experienced, with only intermediate vision described as clear.The surgeon was not able to improve the vision with glasses.A second opinion may have been sought outside the hospital.It was unknown if the issues were resolved.According to the opinion of the surgeon, it was not certain if the product had caused or contributed to the event.Additional information was requested.A questionnaire was received.
Event or Problem Description
Additional information was requested and received stating that the consumer had been examined and that nothing more could be done.A laser procedure was performed to clear up some film or fibers.
Additional Manufacturer Narrative
Additional information was provided in b.5.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Correction information was provided in b.5.And h.6.On initial medical device report (mdr) the fda evaluation codes of b.17 was submitted.It should have been b.20.Additional information was provided in h.3.And h.11.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 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 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 the issues were bilateral.The reporter indicated the issues were from the date of implant.The reporter was encouraged to follow up with their healthcare professional (hcp) or seek a second opinion.The surgeon provided the information that the patient has not been seen by the surgeon since the lenses were implanted in 2021.The patient was seen at the optometry clinic in 2023.The patient did not report any significant visual concerns right after surgery or at the most recent visit in 2023.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was requested and received stating that the surgeon stated that the patient had not been seen since 2021 and was last seen in optometry clinic in 2023.Patient did not report any significant visual concerns right after surgery or at his most recent visit in 2023.

• 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: 22714109
• Report Number: 1119421-2025-02136
• Device Sequence Number: 9611812
• Product Code: MFK
• UDI-Device Identifier: 00380652415019
• UDI-Public: (01)00380652415019(17)250203(11)200205(10)15019085
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/19/2025

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: 02/03/2025
• Device Model Number: TFNT00
• Device Catalogue Number: TFNT00U210
• Device Lot Number: 15019085
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/07/2025
• Supplement Date Received by Manufacturer: 08/05/2025; 09/10/2025
• Initial Report FDA Received Date: 08/05/2025
• Supplement Report FDA Received Date: 08/26/2025; 09/19/2025
• Date Device Manufactured: 02/05/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DUOVISC VISCOELASTIC SYSTEM.; UNKNOWN CARTRIDGE.; UNKNOWN INJECTOR.; UNKNOWN LOADING/ FOLDING FORCEPS.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male