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

Model Number	CNAET0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Endophthalmitis (1835)
Date of Event	10/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The physician stated that following the intraocular lens (iol) implant procedure, patient developed endophthalmitis.Vitreous injection was given to patient and the symptom was subsiding.The patient said the vision was good.Additional information has been requested.
Additional Manufacturer Narrative
The product was not returned for analysis; the lens remains implanted.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).
Additional Manufacturer Narrative
Additional information provided in h.3.And h.11.A product history record review and a non-conformance review of the reported lot number was conducted.No deviations were identified and all corresponding production release specifications defined in the device master record were met.The file states: "doctor's comment: the opinion is that this is not due to the intraocular lens".The root cause for the reported complaint could not be determined.The sterilisation reports were reviewed and there were no issues with the sterilisation process.Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON VIVITY EXTENDED VISION HYDROPHOBIC 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: 23657151
• Report Number: 9612169-2025-02361
• Device Sequence Number: 17349726
• Product Code: POE
• UDI-Device Identifier: 00380652406123
• UDI-Public: (01)00380652406123(17)270423(11)230425(10)25632276
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2026

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: CNAET0
• Device Lot Number: 25632276
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/04/2025
• Supplement Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 01/08/2026
• Date Device Manufactured: 04/25/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown