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

Model Number	CNWTT0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Halo (2227)
Date of Event	06/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A consumer reported that following an intraocular lens (iol) implant procedure, she experienced with halos so big in the nighttime and looking at any bright lights like car lights, signal lights, bike lights, torch lights, decoration lights, streetlights and cannot even see the source of the lights.Which made her difficult to get out of the house in the nighttime and making driving impossible as the hallow lights from the cars opposite side reflection making impossible to see side of the lane.There are two medical device reports associated with this patient.This report is associated with the left eye.Additional information has been requested.
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 and stated, patient experienced halos right from the day of surgery that is (b)(6) 2025.She was told that halos will disappear as the time goes by and she waited for almost six months hoping that they slowly disappear, but they never did.Additional information was received and stated, when the patient stepped out of the house in the evening after two days of the left eye surgery and noticed big halos around all the bright lights of the cars and bikes, but she was told that it was common to see the halos and it takes few days for the brain to get adjusted and the halos never went away she went for lens exchange surgery for right eye but the exchange lens also had its own problems.
Additional Manufacturer Narrative
Additional information was provided inb.3., b.5.And h.11.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON PANOPTIX TRIFOCAL HYDROPHOBIC INTRAOCULAR LENS
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• 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: 24052449
• Report Number: 9612169-2026-00128
• Device Sequence Number: 13098570
• Product Code: MFK
• UDI-Device Identifier: 00380652408219
• UDI-Public: (01)00380652408219(17)281029(11)241031(10)25946417
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2026

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: CNWTT0
• Device Catalogue Number: CNWTT0.245
• Device Lot Number: 25946417
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/24/2025
• Supplement Date Received by Manufacturer: 01/24/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 02/16/2026
• Date Device Manufactured: 10/31/2024
• 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: Other
• Patient Age: 67 YR
• Patient Sex: Female