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	Capsular Contracture (1761); Eye Injury (1845); Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
A non-healthcare professional reported that following the intraocular lens (iol) implant procedure, the patient experienced blurred vision, photophobia, "like looking through a white sheet," loss of binocular vision, iris delamination, transillumination defects, phimosis, and fatigue.The reporter stated that the patient had been receiving treatment at a hospital for the past two years.According to records, the surgeon's calculations called for one company model; however, another model was reportedly received.The reporter stated that the patient was at higher risk for lens explantation due to iris-related issues.The reporter also stated that she did not believe the events were related to a lens issue and initially did not wish to report a complaint.She was informed that the information would be documented and that the lens would be investigated as part of due diligence.
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).

• 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: 50771934
• Report Number: 1119421-2026-01872
• Device Sequence Number: 13402297
• Product Code: MJP
• UDI-Device Identifier: 00380652455244
• UDI-Public: (01)00380652455244(17)260925(11)220927(10)15501212
• Combination Product (Y/N): N
• 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: Consumer
• 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 Expiration Date: 09/25/2026
• Device Model Number: CCWET3
• Device Lot Number: 15501212
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/17/2026
• Initial Report FDA Received Date: 09/15/2026
• Date Device Manufactured: 09/27/2022
• 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: Hospitalization; Required Intervention
• Patient Sex: Male