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 Code	Visual Impairment (2138)
Date of Event	12/30/2024
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 with poor vision.The lens was exchanged for another lens model 10 days following the initial procedure.Clinical reason for explant was mentioned as dissatisfied with vision.Additional information has been requested.
Additional Manufacturer Narrative
The lens was returned on a wet medical sponge placed into a small plastic specimen jar in a biohazard bag.The lens was removed from the jar and allowed to air dry.The optic was broken into pieces with only two portions returned.The large broken chuck of the optic was not returned.The optic has linear cracks from the optic edge toward the optic center in the shape of an instrument used to grasp the lens on the anterior and the posterior optic surfaces.Additional cracked damaged areas were observed between the center and the optic edge on one portion and near the optic edge of another broken optic portion.Product history records were reviewed and documentation indicated the product met release criteria.A qualified cartridge and handpiece were indicated.A non-qualified viscoelastic was indicated.The root cause cannot be determined for the reported complaint of "dissatisfied with vision (explant)".The lens was broken (or cut) into pieces.Not all broken lens portions were returned.Additional lens damage was observed.Each lens was subjected to a 100% assessment of the power and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.The power and resolution of the returned lens could not be re-evaluated due to the optic damage.Information was provided that the company ccwet0 23.5 diopter (1.5 extended depth of focus) lens was removed and replaced with a non-company monofocal lens 23.0 diopter.Due to the exchange of a vivity ccwet0 23.5 diopter (1.5 extended depth of focus) lens for a non-company monofocal 23.0 diopter lens, this suggests that a replacement monofocal lens with one half diopter less power may have been an improved choice for the patient's vision needs.File will be reopened if new information is received.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; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 21263034
• Report Number: 1119421-2025-00242
• Device Sequence Number: 9538546
• Product Code: POE
• UDI-Device Identifier: 00380652405843
• UDI-Public: (01)00380652405843(17)260514(11)220516(10)15409551
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2025

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 Expiration Date: 05/14/2026
• Device Model Number: CCWET0
• Device Catalogue Number: CCWET0.235
• Device Lot Number: 15409551
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/03/2025
• Supplement Date Received by Manufacturer: 02/07/2025
• Initial Report FDA Received Date: 01/29/2025
• Supplement Report FDA Received Date: 03/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2022
• 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: AMVISC PLUS.; B&L MX60EE 23.00; CLAREON MONARCH IV INJECTOR.; CLAREON MONARCH IV IOL DELIVERY SYSTEM, INJECTOR.; MONARCH II LOADING FORCEPS.; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown