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 Code	UGH (Uveitis Glaucoma Hyphema) Syndrome (4470)
Date of Event	02/11/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A sample device 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 non-health care professional reported that during an intraocular lens (iol) implant procedure, there was a tear in the posterior capsule (pc).However, the surgeon opted to continue on course and implant the company iol into the sulcus.Following the procedure, the patient developed uveitis glaucoma hyphema (ugh) syndrome due to the single piece iol being in the sulcus.The iol was exchanged for unspecified 3-piece monofocal iol in a secondary procedure.Additional information has been requested, received and stated in the surgeon¿s opinion, product did not cause the event, it was the location of the product in the sulcus that was the issue.It was mentioned if there would not have been a pc tear/bag break, this wouldn't be an issue, but the surgeon had no choice but to place in sulcus, that was the issue.The lens was exchanged with non-company lens.There was no further impact to the patient and healing well with iol in good position.
Additional Manufacturer Narrative
The lens was returned taped to surgical gauzes.Blood and solution was dried on the lens.The lens was cleaned with klrp for further evaluation.The optic was torn and had multiple scuff marks and small cracks on the anterior and posterior sides in the shape of an instrument used to grasp the lens.The damage observed is typical of insertion and removal.Power and resolution testing could not be conducted due to the extensive optic damage.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.Information was provided that the issue was not related to the iol.A pc-tear occurred before the lens was implanted.The surgeon chose to place the posterior chamber lens in the sulcus due to the pc tear.Per the instructions for use (ifu): the company iols are intended to be positioned in the lens capsule in the posterior chamber of the eye.Information was provided that the multifocal company 12.0 diopter, add power +2.2 & 3.2 lens model was replaced with a non-company multipiece monofocal (10.5 diopter).The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ PANOPTIX UV ABSORBING 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: 25216001
• Report Number: 1119421-2026-01081
• Device Sequence Number: 9778814
• Product Code: MFK
• UDI-Device Identifier: 00380652429559
• UDI-Public: (01)00380652429559(17)260224(11)210226(10)15152752
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2026

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: 02/24/2026
• Device Model Number: TFAT00
• Device Catalogue Number: TFAT00.120
• Device Lot Number: 15152752
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/01/2026
• Supplement Date Received by Manufacturer: 06/01/2026
• Initial Report FDA Received Date: 05/19/2026
• Supplement Report FDA Received Date: 06/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: AMVISC PLUS.; GRIESHABER IOL LOADING FORCEPS.; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D.; MONARCH III IOL DELIVERY SYSTEM, INJECTOR.
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Male