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 Code	Blurred Vision (2137)
Date of Event	03/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A non-healthcare professional reported that, following intraocular lens implantation surgery, the patient experienced poor vision/depth perception.Hence the lens was explanted and replaced with a non- company iol in a secondary procedure.The clinical reason for explant was other mechanical complications of lens.Additional information has been requested and received that there was no further impact to the patient.
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.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.

• 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: 50769421
• Report Number: 1119421-2026-01867
• Device Sequence Number: 10416520
• Product Code: MJP
• UDI-Device Identifier: 00380652455374
• UDI-Public: (01)00380652455374(17)280817(11)240819(10)15893916
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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): 09/15/2026

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: 15893916
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/19/2026
• Initial Report FDA Received Date: 09/15/2026
• Date Device Manufactured: 08/19/2024
• 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: LAL +24.0 D SN (b)(6); ORA System with VerifEye Messaging, Cart; UNSPECIFIED Ophthalmic ViscoSurgical Device; Unspecified forceps; Unspecified monarch handpiece
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female