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

Model Number	CCWET0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dry Eye(s) (1814); Blurred Vision (2137)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned for analysis.The reporter stated that the company lens was replaced with a monofocal lens.The root cause for the reported complaint could not be determined.The exchange to a monofocal lens may suggest that the replacement lens model was an improved choice for the patient's vision needs.According to the instructions for use (ifu), patients implanted with the company intraocular lens (iol) may experience bothersome visual disturbances, which in some cases may be significant enough to lead to a request for iol explantation.Additionally, the ifu notes that most patients are likely to experience a reduction in contrast sensitivity compared to those implanted with a monofocal iol.Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is:(b)(4).
Event or Problem Description
A consumer reported that after cataract surgery with intraocular lens (iol) implantation, he experienced blurry vision.He was not happy with the vision.He could see street signs slightly at about 20 feet.Consequently, the lens was removed and replaced with a monofocal lens in a secondary procedure.The clinical reason for explant was that the patient had very dry eye and was not tolerating the iol.Additional information was requested, but no further information is available.

• Brand Name: CLAREON VIVITY EXTENDED VISION UV ABSORBING 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: 23777040
• Report Number: 9612169-2025-02476
• Device Sequence Number: 13281699
• Product Code: POE
• UDI-Device Identifier: 00380652405652
• UDI-Public: (01)00380652405652(17)270418(11)230420(10)25631411
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/11/2025

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: CCWET0
• Device Lot Number: 25631411
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 12/11/2025
• Date Device Manufactured: 04/20/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male