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

Model Number	CCWET3
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Disturbances (2140)
Type of Reportable Event	Serious Injury
Event or Problem Description
A non-healthcare professional reported that following the intraocular lens (iol) implant procedure, patient experienced poor low light vision which made driving impossible at night.The vision in artificial light focus field limited to 10 yards and driving at night was impossible with no available mid or distance focus, huge glare off reflective signs and headlights.Additional information requested and received that patient discussed with the surgeon about symptoms and was said eye was healthy and the surgery appears to be flawless.
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).

• Brand Name: Clareon Vivity Toric Extended Vision 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: 50207882
• Report Number: 1119421-2026-01676
• Device Sequence Number: 13371171
• Product Code: MJP
• UDI-Device Identifier: 00380652455350
• UDI-Public: (01)00380652455350(17)280114(11)240116(10)15775882
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/11/2026

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: CCWET3
• Device Lot Number: 15775882
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/17/2026
• Initial Report FDA Received Date: 08/11/2026
• Date Device Manufactured: 01/16/2024
• 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 Cartridge D; MONARCH III Injector; PROVISC; VISCOAT; mcpherson forceps
• Outcome Attributed to Adverse Event: Other
• Patient Age: 75 YR
• Patient Sex: Male