MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON VIVITY EXTENDED VISION HYDROPHOBIC IOL; EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS

Model Number	CNWET0
Medical Device Problem Codes	Failure to Deliver (2338); Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2026
Type of Reportable Event	Malfunction
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 physician reported that during intraocular lens implantation surgery, while loading the lens was scratched.There was no patient contact and the surgery was completed on the same day.Additional information was received and it states that the surgeon reports a lot of resistance when trying to release lens.In the surgeon¿s opinion, issue identified when it was going to be dispensed.

• Brand Name: CLAREON VIVITY EXTENDED VISION HYDROPHOBIC IOL
• Common Device Name: EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS
• Manufacturer (Section D): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer (Section G): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 24845448
• Report Number: 9612169-2026-00834
• Device Sequence Number: 21064428
• Product Code: POE
• UDI-Device Identifier: 00380652405256
• UDI-Public: (01)00380652405256(17)270207(11)230209(10)25580331
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CNWET0
• Device Catalogue Number: CNWET0.205
• Device Lot Number: 25580331
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/19/2026
• Supplement Date Received by Manufacturer: 06/26/2026
• Initial Report FDA Received Date: 04/10/2026
• Supplement Report FDA Received Date: 07/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2023
• 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, INJECTOR; MONARCH II LOADING FORCEPS; MONARCH III IOL, CARTRIDGE D; PROVISC
• Patient Sex: Unknown