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	Blurred Vision (2137); Visual Disturbances (2140)
Date of Event	05/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A non-health care professional reported that following an intraocular lens (iol) implant procedure, since 2 days post-op the patient had negative dysphotopsia in left eye and no intermediate vision.As a lifelong contact lens wearer not having to wear glasses for intermediate vision was a top priority.Patient had good distance vision but had to put one pair of glasses to see the computer, another pair of glasses to read.Additional information was received stating that symptoms had improved slightly since yag (yttrium-aluminum-garnet) laser was performed.Ophthalmologist suggested "reverse optic capture" procedure for the dysphotopsia patient experienced.
Additional Manufacturer Narrative
The product was not returned.Product history records were reviewed, and the documentation indicated the product met release criteria.The account indicated the use of qualified associated products.The product investigation could not identify a root cause for the reported complaint.The account indicated the product was not available to evaluate, as the lens remains implanted.Each lens is subjected to a 100 percent assessment of the power and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.Additional information was provided that the patient reported additional consultations with surgeon, and after having yag (yttrium-aluminum-garnet) laser surgery, symptoms have improved slightly.Patient was being seen by an ophthalmologist that suggested a "reverse optic capture" procedure for the dysphotopsia.Due diligence has been performed in an attempt to obtain further information on this event.Consumer stated would contact company if there were any more details.File will be reopened when 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; 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: 21700649
• Report Number: 1119421-2025-00847
• Device Sequence Number: 12740198
• Product Code: POE
• UDI-Device Identifier: 00380652405737
• UDI-Public: (01)00380652405737(17)260601(11)220603(10)15417777
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 03/26/2025

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: 06/01/2026
• Device Model Number: CCWET0
• Device Catalogue Number: CCWET0.180
• Device Lot Number: 15417777
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/26/2025
• Initial Report FDA Received Date: 03/26/2025
• Date Device Manufactured: 06/03/2022
• 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: CLAREON MONARCH IV INJECTOR; DUOVISC; MONARCH II LOADING FORCEPS; MONARCH III CARTRIDGE D
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female