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); Visual Disturbances (2140)
Date of Event	09/24/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned for analysis.Complaint history and product history record could not be reviewed because the reporting facility did not provide a valid lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A facility representative reported that following an intraocular lens (iol) implant procedure, patient was unhappy with night visual acuity and experienced wobbly vision, halo vision, blurry night visual acuity and light sensitivity.The lens was exchanged with unspecified monofocal iol after the initial implant procedure.The clinical reason for explant was lens intolerance, photopsia and blurry vision.There are two medical device reports associated with this patient.(this is 1 of 2).
Additional Manufacturer Narrative
Additional information was provided in b.5, a2, a3.A, b5, b6, and d10.Based on information received following submission of the initial report, this event does not meet criteria for reporting as a serious injury.No further reports required.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information received stating that lens was exchanged with company another model lens.Patient's issue was resolved.There is no reported defect or fault with the iol.

• 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: 22750263
• Report Number: 9612169-2025-01604
• Device Sequence Number: 13102292
• Product Code: POE
• UDI-Device Identifier: 00380652405171
• UDI-Public: (01)00380652405171(17)250322(11)211029(10)25289563
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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,Followup
• Report Date (Section B): 09/04/2025

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: 03/22/2025
• Device Model Number: CNWET0
• Device Catalogue Number: CNWET0.165
• Device Lot Number: 25289563
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/21/2025
• Supplement Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 08/08/2025
• Supplement Report FDA Received Date: 09/04/2025
• Date Device Manufactured: 10/29/2021
• 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 ASPHERIC HYDROPHOBIC ACRYLIC IOL; CLAREON MONARCH IV IOL DELIVERY SYSTEM; MONARCH II LOADING FORCEPS; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE; REPLACEMENT LENS: UNSPECIFIED MONOFOCAL
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male