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	Blurred Vision (2137); Visual Impairment (2138)
Date of Event	06/30/2025
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 experienced blurry day vision.The iol was exchanged for unspecified lens model 1 month and 5 days after the initial implant procedure.Clinical reason for explant was reported as residual astigmatism.Additional information has been received and stated that the patient can't read street signs or can't see her phone.The patient issues were resolved.

• 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 ; 8007579780
• MDR Report Key: 22936209
• Report Number: 1119421-2025-02366
• Device Sequence Number: 21358989
• Product Code: MJP
• UDI-Device Identifier: 00380652455275
• UDI-Public: (01)00380652455275(17)271024(11)231026(10)15736029
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/02/2025

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: 15736029
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 09/02/2025
• Date Device Manufactured: 10/26/2023
• 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: MONARCH II FORCEPS.; MONARCH III IOL, CARTRIDGE D.; MONARCH III IOL, INJECTOR.; PROVISC OVD.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female