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); Diplopia/Double Vision (4802)
Date of Event	03/21/2025
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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
Event or Problem Description
A non-healthcare professional reported after intraocular lens (iol) implant procedure, the patient was happy with the vision in the first post-op appointment.However, he reported that the prescribed unspecified medicated eye drops really burned his eyes.Two days after the appointment he noticed change in his vision i.E, some double vision or shadow vision.Next week in surgeon appointment he stated that a film might be developing on the lens.The patient could not tell much difference between right or left eye.The patient also reiterated that the drops were really burning his eyes.Surgeon gave him drops that did not have one of the medications in them.These also burned patient eyes.Surgeon stated that the film could be removed later and that should help clear up the problem.1 month post op the patient still have double vision & blurred vision.Surgeon stated we can do a capsulotomy to try to fix the problem.A capsulotomy was performed, and it did not help.Lasik was suggested to correct it and surgeon suggested to wear glasses but unfortunately, they also didn¿t help.There are two medical device reports associated with this patient.This report is associated with the right eye.Additional information was requested.
Event or Problem Description
Additional information was requested and received stating that there was no patient harm.
Additional Manufacturer Narrative
Additional information was provided in b.5., b.6., d.10.And h.11.The product was not returned.A device history record review and a non-conformance review of the reported lot number was conducted.The deviation review did not reveal any potential contributing factors to the reported complaint and all corresponding production release specifications defined in the device master record were met.The product investigation could not identify a root cause for the reported complaint.The lens remains implanted.Each lens is subjected to a 100-percentage assessment of the power and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.The reporter was the patient.Information was provided that indicated the bilateral implants were done a day apart.The reporter was very happy with their vision at 1-week post-op.Noticed vision change 2 days later.Based on the information provided this was a clear lens exchange.The surgeon provided information that a yag (yttrium aluminum garnet) was done.The manufacturer internal reference number is: (b)(4).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.

• 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: 22936911
• Report Number: 1119421-2025-02373
• Device Sequence Number: 10107229
• Product Code: POE
• UDI-Device Identifier: 00380652405782
• UDI-Public: (01)00380652405782(17)280717(11)240719(10)15893900
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2025

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: 15893900
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/11/2025
• Supplement Date Received by Manufacturer: 10/02/2025
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 10/24/2025
• Date Device Manufactured: 07/19/2024
• 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: CLAREON MONARCH IV IOL DELIVERY SYSTEM, INJECTOR; DUOVISC VISCOELASTIC SYSTEM; MONARCH II LOADING FORCEPS; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; UNSPECIFIED EYE DROPS (1); UNSPECIFIED EYE DROPS (2)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male