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 Codes	Blurred Vision (2137); Visual Disturbances (2140)
Date of Event	04/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A product was not returned for analysis.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.
Event or Problem Description
A consumer reported that following an intraocular lens (iol) implant procedure, the patient vision was smudgy and experienced halo's due to that the patient cannot drive at night.Surgeon tried laser, then prescribed a prescription eye drops post surgery, it then that tapered off and that helped.Two weeks ago, the patient saw your eye care provider for the last time and now the surgeon suggested to get glasses.Additional information has been requested.There are two medical device reports associated with this patient.This report is associated with the left eye.
Additional Manufacturer Narrative
Corrected information provided in b.5.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.
Event or Problem Description
Additional information was received stating that the patient¿s vision had improved to a degree.The main issue reported was that everything was ¿fuzzy,¿ as if the patient was ¿wearing glasses that are smeared with something that did not go away and were there 24 hours.¿ the consumer reported that the halos prevented the patient from seeing at night, and the patient could no longer drive at night.The consumer also reported that this situation caused depression and anxiety because the patient had been extremely active and vacationed frequently but could not do that now.

• 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: 24597964
• Report Number: 1119421-2026-00538
• Device Sequence Number: 9561490
• Product Code: MFK
• UDI-Device Identifier: 00380652408073
• UDI-Public: (01)00380652408073(17)250108(11)210817(10)15253590
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2026

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: 01/08/2025
• Device Model Number: CNWTT0
• Device Catalogue Number: CNWTT0.175
• Device Lot Number: 15253590
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/21/2026
• Supplement Date Received by Manufacturer: 03/14/2026
• Initial Report FDA Received Date: 03/13/2026
• Supplement Report FDA Received Date: 04/08/2026
• Date Device Manufactured: 08/17/2021
• 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