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 Codes	Device Difficult to Setup or Prepare (1487); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A nurse reported that during an cataract surgery with intraocular lens (iol) implant procedure, that leading haptic was not folded as it was priming through cartridge for insertion with no patient contact, it was also stated that procedure was completed on the same day with no patient harm.Additional information has been requested.
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).
Additional Manufacturer Narrative
Corrected information provided in h.6 and h.11.On initial mdr the product code should have been a2201 instead of a040609.Based on information received following submission of the initial report, this event does not meet criteria for reporting as a malfunction.No further reports required.Additional information was provided in b.2., d.9., h.3., h.6.And h.11.The product was returned for analysis and the reported complaint could not be observed.The intraocular lens (iol) was returned outside of the device.The device was received loose in the product carton.The lock-out assembly has been removed.Viscoelastic is observed in the device.The plunger has been fully advanced outside the nozzle.Stress and aneurysm observed on the nozzle tip.The lens was returned outside of the device.Solution is dried on the intraocular lens (iol).50 percent of one haptic is broken/torn.The product investigation could not identify the root cause for the reported complaint "leading haptic was not folded" as the intraocular lens (iol) was returned outside of the device.Due to this, we are unable to confirm the lens and the plunger position for advancement and determine a root cause.Damage was observed to the tip of the nozzle.The observed damage typically occurs if there is a lack of viscoelastic between the lens and the nozzle lumen and/or if the plunger is not positioned correctly at the trailing optic edge for advancement.This can allow the lens to fold around the plunger tip making it too large to correctly advance through the narrow tip of the nozzle causing damage or become stuck.Any of the above factors alone, or in combination, may lead to an event such as reported.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: 22861042
• Report Number: 9612169-2025-01685
• Device Sequence Number: 7622807
• Product Code: POE
• UDI-Device Identifier: 00380652406338
• UDI-Public: (01)00380652406338(17)280611(11)240613(10)25867054
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: CNAET0
• Device Lot Number: 25867054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/28/2025
• Supplement Date Received by Manufacturer: 10/14/2025
• Initial Report FDA Received Date: 08/21/2025
• Supplement Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2024
• 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: PROVISC OVD
• Patient Sex: Female