MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON 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	Visual Impairment (2138); Visual Disturbances (2140)
Date of Event	03/31/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility representative reported that following an intraocular lens (iol) implant procedure, the patient experienced glare and halos as well as myopic result and clinical reason for explant being s/p lasik -0.75 refraction post 1st surgery.The iol was explanted and exchanged for an unknown atiol following the initial implant procedure.Additional information has been requested and received stating that the patient came in for 2 week post op c/o debilitating glare and halos at night, was unable to drive.The surgeon believed that the patient was unable to get used to multifocality of iol.The patient issues had resolved.Lens was exchanged with a non-company lens.
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).
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The lens was returned in a plastic specimen cup.Solution was dried on the lens.The lens was cleaned with klrp for further evaluation.The lens was allowed to dry.The optic had deep scuff marks/cracks on the anterior and posterior sides in the central optic zone in the shape of an instrument used to grasp the lens.This damage is typical of insertion and removal.A power and resolution tests were attempted by an engineering technician.The lens met specification for power (21.0 diopter) for a company 21.0 diopter lens.The optical resolution could not be 100% confirmed due to the areas of optic damage on the returned lens.Product history records were reviewed and documentation indicated the product met release criteria.Qualified associated products were indicated.However, they are not relevant to the reported complaint.The product investigation could not identify a root cause for the reported complaint.A power and resolution tests were attempted by an engineering technician.The lens met specification for power (21.0 diopter) for a company 21.0 diopter lens.The optical resolution could not be 100% confirmed due to the areas of optic damage on the returned lens.Information was provided that the "the surgeon believes patient unable to get used to multifocality of iol".The company, 21.0 diopter (extended 1.5 diopters of focus) lens was exchange for a non-company monofocal lens.Due to the exchange of a vivity (extended depth of focus) lens to a monofocal lens may suggest that the replacement lens model was an improved choice for the patient's vision needs.Information was provided that patient had myopic lasik with enhancement prior to surgery.The patient's issues have resolved.The surgeon's prognosis is good.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON VIVITY EXTENDED VISION UV ABSORBING IOL
• Common Device Name: EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS
• 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: 22017241
• Report Number: 1119421-2025-01391
• Device Sequence Number: 8778850
• Product Code: POE
• UDI-Device Identifier: 00380652405799
• UDI-Public: (01)00380652405799(17)280605(11)240607(10)15863701
• 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,Followup,Followup
• Report Date (Section B): 12/09/2025

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: 15863701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/18/2025
• Supplement Date Received by Manufacturer: 05/15/2025; 11/13/2025
• Initial Report FDA Received Date: 05/14/2025
• Supplement Report FDA Received Date: 06/06/2025; 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2024
• 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: MONARCH II LOADING FORCEPS.; MONARCH III IOL , CARTRIDGE D.; MONARCH III IOL, INJECTOR.; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE.
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown