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	Visual Impairment (2138); Visual Disturbances (2140)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lens was returned in a small plastic container, inside a specimen cup.Solution was dried on the lens.The optic was cut from edge past center of the lens, typical of insertion and removal.Power and resolution testing could not be conducted due to the extensive optic damage.The product investigation could not identify a root cause for the reported complaint.Each lens was 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 power and resolution of the returned lens could not be re-evaluated due to the extensive optic damage.The file indicated that the company 19.5 diopter (add power +2.2/+3.2) lens was replaced with a another model company 20.5 diopter, (1.5 extended depth of focus) lens.Due to the exchange for a 1.0 higher diopter difference lens model may suggest that the replacement lens was an improved choice for the patient's vision needs.No additional information provided.No additional information has been provided at this time.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A facility representative reported that following an intraocular lens (iol) implant procedure, the patient had major halos around lights, constant in all lighting, could not tolerate multifocal lens.The explant was scheduled.Additional information has been requested, received and stated the lens was explanted and exchanged with another model 1 diopter more company lens.Additional information has been received and stated the clinical reason for the explant was mentioned as significant glare and inability to drive.

• 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: 22860961
• Report Number: 1119421-2025-02298
• Device Sequence Number: 13096220
• Product Code: MFK
• UDI-Device Identifier: 00380652357722
• UDI-Public: (01)00380652357722(17)270221(11)220223(10)15361214
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: 2025
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/21/2025

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: TFNT00
• Device Catalogue Number: TFNT00.195
• Device Lot Number: 15361214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/01/2025
• Initial Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female