MAUDE Adverse Event Report: Alcon Research, LLC - Huntington Clareon PanOptix Toric Trifocal UV Absorbing IOL; Lens, Intraocular, Toric Optics

Model Number	CCWTT3
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blurred Vision (2137)
Type of Reportable Event	Serious Injury
Event or Problem Description
A non-healthcare professional reported that, following intraocular lens implantation surgery, the lens did not work, and the patient experienced poor quality of vision.Hence the lens was explanted and replaced with another atiol (advanced technology intra ocular lens) in a secondary procedure.Additional information was requested and received, confirming that there was no further impact on the patient and that the patient's symptoms have resolved.
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).

• Brand Name: Clareon PanOptix Toric Trifocal UV Absorbing IOL
• Common Device Name: Lens, Intraocular, Toric Optics
• 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 ; +1(800)757-9780
• MDR Report Key: 50545179
• Report Number: 1119421-2026-01798
• Device Sequence Number: 10651346
• Product Code: MJP
• UDI-Device Identifier: 00380652457194
• UDI-Public: (01)00380652457194(17)280728(11)240730(10)15899044
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/01/2026

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: CCWTT3
• Device Catalogue Number: CCWTT3.105
• Device Lot Number: 15899044
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/07/2026
• Initial Report FDA Received Date: 09/01/2026
• Date Device Manufactured: 07/30/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MONARCH III IOL Delivery System, Cartridge D.; MONARCH III IOL Delivery System, Injector.; PROVISC Ophthalmic ViscoSurgical Device.; unspecified forceps.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown