MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON PANOPTIX TORIC TRIFOCAL HYDROPHOBIC IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	CNWTT3
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Headache (1880); Visual Disturbances (2140)
Date of Event	01/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A nonhealth care professional reported that after the intraocular lens (iol) implantation surgery, the patient experienced halos and could not drive at night.The halos was very bad around the lights that he could not drive at night.There are two files associated with this report.This is 1 of 2.
Additional Manufacturer Narrative
The product was not returned for analysis; the lens remains implanted.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
Additional information was received stating that, the patient got headaches every day from any type of lighting.Using her computer or phone for any length of time was hurting her eyes, huge halos and star bursts around lights at night and haziness around lights during the day.The physician stated that, some of the issues was due to the patient's light eyes (blue).The physician had provided eye drops to the patient, which burn terribly when it was put in the eye.They made everything dark and even more difficult to drive at night.The physician also suggested to try ar yellow lenses which just turned the halos yellow.
Additional Manufacturer Narrative
Additional information was provided in b.5., b.7., d.4., d.6.A., and h.6.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON PANOPTIX TORIC TRIFOCAL HYDROPHOBIC IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer (Section G): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 24158659
• Report Number: 9612169-2026-00177
• Device Sequence Number: 9129605
• Product Code: MJP
• UDI-Device Identifier: 00380652468558
• UDI-Public: (01)00380652468558(17)281218(11)241220(10)25962265
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2026

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 Model Number: CNWTT3
• Device Catalogue Number: CNWTT3.210
• Device Lot Number: 25962265
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/29/2025
• Supplement Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 01/23/2026
• Supplement Report FDA Received Date: 04/06/2026
• Date Device Manufactured: 12/20/2024
• 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; Other
• Patient Age: 75 YR
• Patient Sex: Female