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 Codes	Particulates (1451); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Insufficient Information (4580); Posterior Capsule Opacification (4807)
Date of Event	01/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A product 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 nurse reported with a description of intraocular lens was rotated from 90 degrees to 80 degrees.Additional information has been requested.
Additional Manufacturer Narrative
D.3.Product manufacturing site updated due to receipt of serial number g.8.Manufacturer report number corrected and reported under 1119421-2025-01469.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been received and stated that the grade 2 pco at 3 months, iol was rotated axis from 12 degrees to 30 degrees, concerned regarding the lens material verses cartridge material causing the lens to be slick and rotate.The surgeon noticed cartridge material adheres to posterior surface of les requiring removal with irrigation and aspiration but that can sometimes be difficult.

• 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: 21839907
• Report Number: 9612169-2025-00585
• Device Sequence Number: 7851897
• Product Code: MJP
• UDI-Device Identifier: 00380652455305
• UDI-Public: (01)00380652455305(17)271216(11)231218(10)15768683
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2025

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: CCWET3
• Device Lot Number: 15768683
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/17/2025
• Supplement Date Received by Manufacturer: 04/29/2025
• Initial Report FDA Received Date: 04/15/2025
• Supplement Report FDA Received Date: 05/23/2025
• Date Device Manufactured: 12/18/2023
• 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: CLAREON MONARCH IV IOL , INJECTOR.; DUOVISC OVD.; MONARCH II LOADING FORCEPS.; MONARCH III IOL , CARTRIDGE D.; MONARCH IOL , CARTRIDGE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR
• Patient Sex: Male