MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON VIVITY EXTENDED VISION UV ABSORBING IOL W/AUTONOME DELIVERY SYSTEM; EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS

Model Number	CCAET0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Impairment (2138); Visual Disturbances (2140); Diplopia/Double Vision (4802)
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 the intraocular lens (iol) the patient experienced poor quality of vision and double vision.Clinical reason mentioned was decreased contrast, update in refraction not beneficial.Additional information received and stated that the patient experienced glare, strobe lights and unclear vision.The intraocular lens (iol) exchange has been performed due to patient¿s dissatisfaction.The exchange was performed by another surgeon.There was no further impact to the patient.The patient issue had been resolved post iol exchange.The surgeon¿s prognosis was excellent.

• Brand Name: CLAREON VIVITY EXTENDED VISION UV ABSORBING IOL W/AUTONOME DELIVERY SYSTEM
• 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: 24469982
• Report Number: 9612169-2026-00445
• Device Sequence Number: 9581739
• Product Code: POE
• UDI-Device Identifier: 00380652406819
• UDI-Public: (01)00380652406819(17)280414(11)240416(10)25835144
• Combination Product (Y/N): N
• Initial Reporter State: WY
• 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
• Report Date (Section B): 02/27/2026

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: CCAET0
• Device Lot Number: 25835144
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 02/27/2026
• Date Device Manufactured: 04/16/2024
• 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.; LI61AO 20.0.; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE C.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female