MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON 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	Visual Disturbances (2140)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A product was not returned for analysis.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.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non-healthcare professional reported that after the intraocular lens (iol) implantation surgery, the patient could not drive at night because the halos were so large around everything.Even inside the home, there was glare around any lights.The doctor treated cloudiness behind the lens, but it did not improve anything.It had been almost a year, and the condition had not improved over time.There are two medical device reports associated with this patient.This report is 2 of 2.
Additional Manufacturer Narrative
Additional information was provided in a.2 and d.4.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was received stating the patient was getting headaches every day from any type of lighting.The patient experienced huge halos and starbursts around lights at night and haziness around lights during the day.Using a computer or phone for any length of time was hurting the patient¿s eyes.The patient was initially told to wait.The doctor then tried eye drops, which burned terribly when used.The patient reported the eye drops made everything dark and made driving at night even more difficult.The doctor also suggested trying ar yellow lenses, which turned the halos yellow.The patient stated they could not see any clearer and would have preferred to stay with reading glasses.The patient reported that the doctor said part of the issue was that the patient had light eyes (blue).The patient stated these lenses should never be put in any light eyes.

• Brand Name: CLAREON PANOPTIX TRIFOCAL HYDROPHOBIC INTRAOCULAR LENS
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• 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: 24129247
• Report Number: 1119421-2026-00159
• Device Sequence Number: 5456311
• Product Code: MFK
• UDI-Device Identifier: 00380652408127
• UDI-Public: (01)00380652408127(17)280820(11)240822(10)15908893
• 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
• Reporter Type: Manufacturer
• 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: CNWTT0
• Device Catalogue Number: CNWTT0.200
• Device Lot Number: 15908893
• 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: 01/21/2026
• Supplement Report FDA Received Date: 04/06/2026
• Date Device Manufactured: 08/22/2024
• 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: 76 YR
• Patient Sex: Female