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 Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Impairment (2138)
Date of Event	03/10/2025
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).
Event or Problem Description
A non-health care professional reported that following an intraocular lens (iol) implant procedure, the patient experienced residual refractive error.Clinical reason being mentioned as patient prefers multifocal iol.The iol was explanted and exchanged with an unknown atiol (advanced technology intraocular lens) in the secondary implant procedure.Additional information was received by stating, there was no further impact to the patient.
Additional Manufacturer Narrative
Correction information has been provided in section h.6.In the initial medical device report (mdr), the fda patient code e083901 was inadvertently omitted.It has now been added.The manufacturer internal reference number is: (b)(4).

• 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: 22892019
• Report Number: 9612169-2025-01704
• Device Sequence Number: 21045657
• Product Code: POE
• UDI-Device Identifier: 00380652405010
• UDI-Public: (01)00380652405010(17)271126(11)231128(10)25761779
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2025

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: CNWET0
• Device Catalogue Number: CNWET0.085
• Device Lot Number: 25761779
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/31/2025
• Supplement Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 08/26/2025
• Supplement Report FDA Received Date: 11/10/2025
• Date Device Manufactured: 11/28/2023
• 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.; FORCEPS: MCPHERSON.; MONARCH II IOL, CARTRIDGE B.; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown