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 Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Corneal Edema (1791); Blurred Vision (2137); Eye Pain (4467)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned for analysis; the lens remains implanted.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 consumer reported that following an intraocular lens (iol) implant procedure, the patient vision was not as expected after surgery.She has not seen improved vision since implantation.It took 6 months before she could be fit for glasses which have not helped.She has been told she will not have 20/20 vision again in this eye.After surgery she had some corneal swelling.She experiences pain and pinching sensation in the eye.She has a history of dry eye syndrome.She uses unspecified preservative free artificial tear (pfat) as needed for that.She had a second opinion by a surgeon who said she will not have 20/20 vision and did not recommend removing the lens.But that everything looked normal.She could only see up close, but that was not great either.She felt very unhappy because she spent a lot of money on company lens and the surgery and has not gotten anything out of it.She is a secretary and having trouble at work.Her next appointment was scheduled.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: 21901705
• Report Number: 1119421-2025-01180
• Device Sequence Number: 4084777
• Product Code: MJP
• UDI-Device Identifier: 00380652466424
• UDI-Public: (01)00380652466424(17)280304(11)240306(10)15815457
• 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: 2024
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/24/2025

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: CNWET3
• Device Catalogue Number: CNWET3.195
• Device Lot Number: 15815457
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/27/2025
• Initial Report FDA Received Date: 04/24/2025
• Date Device Manufactured: 03/06/2024
• 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: UNSPECIFIED PRESERVATIVE FREE AT DROPS (PFAT)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 66 YR
• Patient Sex: Female