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	Blurred Vision (2137)
Date of Event	01/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A non healthcare professional reported that following an intraocular lens (iol) implant procedure, the patient has no range of vision· patient was seeing 20/25 distance, j10 near.The patient was refracting at minus·25· surgeon tried a plus 1 and plus 1·5 contact lens to see if patient could get more near and intermediate with no effect· pre-operative measurements all consistent, minimal astigmatism, no macular issues· cornea is clear· lens is well centered and normal pupil size.Additional information was received, the lens was explanted and replaced with unspecified lens in a secondary procedure.Additional information has been received and stated that the patient had excellent distance vision but no near vision.No patient harm was reported.
Additional Manufacturer Narrative
The lens was returned in a clear liquid inside a specimen cup.The optic was cut from edge past center, typical of insertion and removal.Power and resolution testing could not be conducted due to the extensive optic damage.Product history records were reviewed and documentation indicated the product met release criteria.Qualified associated products were indicated.The product investigation could not identify a root cause for the reported complaint.Power and resolution testing could not be conducted due to the extensive optic damage.Each lens is subjected to a 100percentage assessment of the power and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.Replacement lens information was not provided.No further information has been provided at this time.File will be reopened and updated 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; 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: 21874314
• Report Number: 1119421-2025-01111
• Device Sequence Number: 7865191
• Product Code: POE
• UDI-Device Identifier: 00380652405713
• UDI-Public: (01)00380652405713(17)260605(11)220607(10)15428760
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/21/2025

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: 06/05/2026
• Device Model Number: CCWET0
• Device Catalogue Number: CCWET0.170
• Device Lot Number: 15428760
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/24/2025
• Initial Report FDA Received Date: 04/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2022
• 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 IOL DELIVERY SYSTEM, INJECTOR.; MONARCH II LOADING FORCEPS.; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D.; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male