MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON IOL WITH THE AUTONOME DELIVERY SYSTEM; INTRAOCULAR LENS

Model Number	CNA0T0
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non-healthcare professional reported that, during intraocular lens implantation surgery, the surgeon noticed that the lens backed out (stuck to the injector) of the eye.The lens was explanted and replaced with another lens during initial procedure.The procedure was completed on the same day.Additional information has been requested.
Additional Manufacturer Narrative
Additional information was provided in d.9., h.3., h.6.And h.11.The product was returned for analysis and the reported complaint could not be observed.The lens was received outside the device.The device was received in a blister tray inside 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.No damage observed.The lens was returned adhered to the outside of the device.Solution is dried on the iol (intraocular lens).Additional information states that the amount of viscoelastic used in the cartridge during loading was 0·1ml.The root cause may be related to failure to follow the ifu (instructions for use).The reporter stated that the amount of viscoelastic used in the cartridge during loading was 0·1ml.The ifu instructs: fill the device until ovd (viscosurgical device) can be observed flowing to the nozzle tip.This will require approximately 0.28 ml of viscoelastic.If inadequate viscoelastic is placed in the device this will cause inadequate coverage of the lens fold path which may cause the lens to advance incorrectly or become ¿stuck¿ in the device.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 IOL WITH THE AUTONOME DELIVERY SYSTEM
• Common Device Name: 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: 22403397
• Report Number: 9612169-2025-01333
• Device Sequence Number: 9978026
• Product Code: HQL
• UDI-Device Identifier: 00380652396448
• UDI-Public: (01)00380652396448(17)270821(11)240822(10)25905253
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2025

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: CNA0T0
• Device Lot Number: 25905253
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/11/2025
• Supplement Date Received by Manufacturer: 08/28/2025
• Initial Report FDA Received Date: 07/04/2025
• Supplement Report FDA Received Date: 09/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2024
• 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.
• Patient Age: 63 YR
• Patient Sex: Female