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 Codes	Inaccurate Delivery (2339); Failure to Advance (2524); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2025
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 non-healthcare professional reported that during an intraocular lens (iol) implant procedure, the lens delivery system failed to work and did not advance the lens forward.The injector failed to deliver the lens during surgery.Additional information was received by stating, there was no patient contact.The procedure was completed on same day.
Additional Manufacturer Narrative
Additional information has been provided in d.9., h.3., h.6., and h.11.Correction information was provided in h.6.On initial medical device report (mdr) the fda product problem codes of a150204 was submitted.It should have been a150101.The product was returned for analysis and the reported complaint was observed.The device was returned loose in a plastic bag.The lock-out assembly has been removed.Viscoelastic is observed in the device.The lens is present in the lens bay.The lever is moving freely and the plunger is not advancing.The device is taken apart for further evaluation.The canister is fully punctured.Krytox is observed on the canister neck.No damage observed to o-rings.The device was reloaded and was reactivated with a new canister.The failure mode could not be replicated; the device activated with no issues.The root cause for the reported complaint is deemed to be manufacturing related (the faulty sub-assembly is supplied by companies vendor in bray).The product did not meet specifications.The plunger is not advancing when the lever is pressed.Based on the results from company product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).

• 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: 23348991
• Report Number: 9612169-2025-02096
• Device Sequence Number: 15820322
• Product Code: POE
• UDI-Device Identifier: 00380652406826
• UDI-Public: (01)00380652406826(17)280414(11)240416(10)25835216
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2025

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: CCAET0
• Device Lot Number: 25835216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/25/2025
• Supplement Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 10/21/2025
• Supplement Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: PROVISC OPHTHALMIC VISCOSURGICAL DEVICE.
• Patient Sex: Unknown