MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON CLAREON VIVITY TORIC EXTENDED VISION HYDROPHOBIC IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	CNWET3
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
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).
Event or Problem Description
A non-healthcare professional reported that following an intraocular lens (iol) implant procedure, the patient needed surgery to rotate the iol.During the attempt to rotate, they were unable to do so because the haptic could not rotate.The iol was exchanged for the same model and same diopter toric lens from the same company following the initial implant procedure.Additional information has been requested.

• Brand Name: CLAREON VIVITY TORIC EXTENDED VISION HYDROPHOBIC 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 ; 8007579780
• MDR Report Key: 22112128
• Report Number: 1119421-2025-01537
• Device Sequence Number: 17908154
• Product Code: MJP
• UDI-Device Identifier: 00380652466448
• UDI-Public: (01)00380652466448(17)280313(11)240315(10)15815459
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/30/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: CNWET3
• Device Lot Number: 15815459
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/14/2025
• Initial Report FDA Received Date: 05/30/2025
• Date Device Manufactured: 03/15/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown