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	02/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lens was returned submerged in a small glass specimen jar with a rubber stopper and screw top lid.The lens was removed from the liquid and allowed to air dry.Residue of viscoelastic was observed on the lens.The lens was cut into two portions with a serrated edged tool.The optic has additional splits from that damage into the optic material.The optic anterior has scratches observed between the optic center and optic edge.The anterior optic edge is nicked.Product history records were reviewed and documentation indicated the product met release criteria.Qualified associated products were used.The product investigation could not identify a root cause for the reported vision complaint.The explanted lens was returned cut into pieces with a serrated edged instrument.Additional lens damage was also observed.Each lens was 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 power and resolution of the returned lens could not be re-evaluated due to the optic damage.An intra ocular lens (iol) exchange for a difference equal to or greater than two diopters, indicates the event may have more likely related to a calculation error.Based on the information provided, the event does not appear to be related to the product.The company lens 19.5 diopter (1.5 extended depth of focus) lens was exchanged for a non-company monofocal 22.25 diopter lens.Due to the exchange of a company extended depth of focus lens for a monofocal design with a difference in diopters from 19.5 to 22.25, this suggests that a monfocal lens design with a higher diopter may have been an improved choice for the patients vision needs.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 was unable to see tv or work on computer and terrible vision.The lens was exchanged for another lens model 02 months 09 days following the initial procedure.Clinical reason for explant was mentioned as mechanical complications.Additional information has been requested.

• 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: 21628481
• Report Number: 1119421-2025-00714
• Device Sequence Number: 12993110
• Product Code: POE
• UDI-Device Identifier: 00380652405768
• UDI-Public: (01)00380652405768(17)280212(11)240214(10)15802919
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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: 2025
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/18/2025

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 Catalogue Number: CCWET0.195
• Device Lot Number: 15802919
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/20/2025
• Initial Report FDA Received Date: 03/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2024
• 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 III IOL DELIVERY SYSTEM, CARTRIDGE D; UNSPECIFIED 0.12 FORCEPS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female