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	Failure to Advance (2524)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/26/2026
Type of Reportable Event	Malfunction
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 pharmacist reported that during surgery, they noticed there was a plunger issue, performed the manipulation of the implant.Additional information has been requested and received stating that the injector broken at the moment of implant insertion.The injector plunger veered to the right from the beginning of the movement.It had to be realigned manually using a micro-manipulation hook.
Additional Manufacturer Narrative
Additional information has been provided in d.9., h.3., h.6., and h.11.The product was returned for analysis and plunger underride was observed.The device was returned loose in the product carton.The lock-out assembly has been removed.Viscoelastic is observed in the device.The plunger has been advanced at the depth guard and is advanced under and to the left side of the iol (intraocular lens).The iol is advanced and strewn between mid-nozzle and the nozzle tip and is damaged.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 root cause for the reported complaint could not be determined.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: 24455603
• Report Number: 9612169-2026-00429
• Device Sequence Number: 10007136
• Product Code: POE
• UDI-Device Identifier: 00380652406345
• UDI-Public: (01)00380652406345(17)290908(11)250910(10)26102739
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CNAET0
• Device Lot Number: 26102739
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/29/2026
• Supplement Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2025
• 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
• Patient Sex: Unknown