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	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
A health care professional reported that following an intraocular lens (iol) implant procedure, the lens was explanted.Additional information has been requested but is not available at the time of this report.
Additional Manufacturer Narrative
A product was not returned for analysis.The investigation reviewed the complaint history data for the reported lot number and found no other similar complaints.Deviation lot search report reviewed; no deviations related to lot.The investigation conducted a nonconformance review of the reported lot number.No deviations were identified and all corresponding production release specifications defined in the device master record were met.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Correction information provided in h.11.The product was not returned for analysis.The root cause for the reported complaint could not be determined as no sample was returned for analysis.The reported complaint is lacking in relevant information such as the type of defect/issue observed.Based on the results from the manufacturing batch record, the products met release criteria.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: 25113236
• Report Number: 9612169-2026-01073
• Device Sequence Number: 13091816
• Product Code: POE
• UDI-Device Identifier: 00380652405294
• UDI-Public: (01)00380652405294(17)280427(11)240429(10)25836128
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2026

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: CNWET0
• Device Catalogue Number: CNWET0.225
• Device Lot Number: 25836128
• 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: 04/10/2026
• Supplement Date Received by Manufacturer: 06/30/2026
• Initial Report FDA Received Date: 05/07/2026
• Supplement Report FDA Received Date: 07/22/2026
• Date Device Manufactured: 04/29/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown