MAUDE Adverse Event Report: Alcon Laboratories Ireland Ltd. Clareon PanOptix Toric Trifocal Hydrophobic IOL; Lens, Intraocular, Toric Optics

Model Number	CNWTT4
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Disturbances (2140)
Type of Reportable Event	Serious Injury
Event or Problem Description
A consumer reported that following an intraocular lens (iol) implant procedure, since the surgery, the patient had experienced persistent halos, starbursts, and severe glare around lights, especially at night.These symptoms began after the implantation of lenses and have had a substantial impact on her daily life.The nighttime glare and halos make it unsafe to drive after dark, forcing her to miss evening activities and depend on family or friends for transportation.Losing the ability to drive at night has significantly reduced her independence and quality of life.Additional information has been requested, yet no new information received.There are two medical device reports associated with this patient.This report is associated with the right eye.
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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.

• 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 ; +1(800)757-9780
• MDR Report Key: 50252256
• Report Number: 9612169-2026-01859
• Device Sequence Number: 18628116
• Product Code: MJP
• UDI-Device Identifier: 00380652469098
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 08/14/2026

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: 02/13/2026
• Device Model Number: CNWTT4
• Device Catalogue Number: CNWTT4.215
• Device Lot Number: 25357096
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/23/2026
• Initial Report FDA Received Date: 08/14/2026
• Date Device Manufactured: 02/15/2022
• 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: Other
• Patient Age: 78 YR
• Patient Sex: Female