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	Visual Impairment (2138)
Date of Event	09/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A sample device was not returned for analysis.Complaint history and product history record could not be reviewed because the reporting facility did not provide a valid lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified the manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non-healthcare professional reported that, after intraocular lens (iol) implantation surgery, the patient experienced mechanical complication of the iol.The clinical reason for explant was myopic outcome.Additional information was requested.
Additional Manufacturer Narrative
Additional information was provided in a.2., a.3.A., b.5., b.6., b.7., d.3., d.4., d.10.And g.9.D.3.Product manufacturing site updated upon receipt of additional information.G.9.Manufacturer report number updated and reported under 1119421-2025-02898.All the additional information going forward will be provided under manufacturer report number 1119421-2025-02898.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was requested and received there was no patient harm.

• 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; model farm road; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 246 kyle lane; model farm road; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 23311158
• Report Number: 9612169-2025-02060
• Device Sequence Number: 5789242
• Product Code: MJP
• UDI-Device Identifier: 00380652455244
• UDI-Public: (01)00380652455244(17)280123(11)240125(10)15785640
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2025

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: 15785640
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/24/2025
• Supplement Date Received by Manufacturer: 10/17/2025
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 11/11/2025
• Date Device Manufactured: 01/25/2024
• 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; TYRE FOLDING FROCEPS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female