MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON VIVITY EXTENDED VISION HYDROPHOBIC IOL; EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS

Model Number	CNWET0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Disturbances (2140)
Type of Reportable Event	Serious Injury
Event or Problem Description
A non healthcare professional reported that, after intraocular lens implantation surgery, the patient was progressively seeing less for distance vision, glare at night and dusk and can only see approximately 8 feet away in grocery store.There are two medical device reports associated with this patient.This report is associated with the left eye.
Additional Manufacturer Narrative
The product was not returned for analysis; the lens remains implanted.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).
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was received stating that, the patient had decided to explant the lens in the left eye.The 20 foot glare lines while driving from dusk until dawn made it difficult for the patient to drive.The patient was hesitant to have both eyes explanted however the patient found driving even with one company lens debilitating.

• Brand Name: CLAREON VIVITY EXTENDED VISION HYDROPHOBIC IOL
• Common Device Name: EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS
• Manufacturer (Section D): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer (Section G): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 21558102
• Report Number: 9612169-2025-00349
• Device Sequence Number: 21113987
• Product Code: POE
• UDI-Device Identifier: 00380652405287
• UDI-Public: (01)00380652405287(17)280120(11)240122(10)25783910
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2026

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: CNWET0
• Device Catalogue Number: CNWET0.220
• Device Lot Number: 25783910
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/10/2025
• Supplement Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 03/10/2025
• Supplement Report FDA Received Date: 02/27/2026
• Date Device Manufactured: 01/22/2024
• 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: Other
• Patient Age: 65 YR
• Patient Sex: Unknown