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); Posterior Capsule Opacification (4807)
Date of Event	09/01/2023
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, since that time, patient experienced visual disturbances associated with lights in that eye, mostly when moving the eye from left to right.Sometimes, it appears that a film or haziness covers the central vision for about 5 seconds before it clears.They always get a starbursts associated with light.These starbursts will rotate in circles around each point of light for about 5 seconds before they begin to clear.However, as soon as they moved the eye from left to right, the starbursts come back and do the same thing again.When driving at night, these starbursts will occur around every point of light, so it was quite disturbing.They also experienced a haze in the entire field of vision in that eye if light enters at a certain angle from above.The ophthalmologist has been unable to offer any explanation as to why this might be happening.They had yag surgery, but there was no change in the issues with light.Patient still experiencing all of these issues.It was not only annoying, but dangerous when driving at night.Additional information has been received as patient did have a posterior capsule opacification in that eye after surgery.They was hoping that was what was causing the issues, but there was no change after they had the yag surgery.Patient have discussed the problems with the doctor at every visit.
Additional Manufacturer Narrative
Additional information was added in b.5, b.7., e.1., h.3.And h.11.The product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.Associated product information was not provided.The product investigation could not identify a root cause for the reported complaint.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.The patient was the reporter.Follow up phone call indicated vision issues continue for the oculus sinister (os).The patient confirmed there was no issue reported for the oculus dexter (od) eye.The patient has a prior history of lasik for both eyes.The patient indicated intention of seeking a second opinion outside of the implanting surgeon's office for the os eye.File will be reopened if new information or the sample is received.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been received from patient stating she experienced swirling in her vision when she sees headlights at night.This lasts for about 5 seconds in the left eye only.

• 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: 20736967
• Report Number: 1119421-2024-02265
• Device Sequence Number: 8649021
• Product Code: POE
• UDI-Device Identifier: 00380652405768
• UDI-Public: (01)00380652405768(17)260208(11)220210(10)15346072
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2025

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 Expiration Date: 02/08/2026
• Device Model Number: CCWET0
• Device Catalogue Number: CCWET0.195
• Device Lot Number: 15346072
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/27/2024
• Supplement Date Received by Manufacturer: 03/18/2025
• Initial Report FDA Received Date: 11/20/2024
• Supplement Report FDA Received Date: 04/09/2025
• Date Device Manufactured: 02/10/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 55 YR
• Patient Sex: Female