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

Model Number	CNA0T0
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A product was not returned for analysis.Complaint history and product history record could not be reviewed because the reporting facility did not provide a valid lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non-healthcare professional reported that a product that failed during surgery.Additional information has been requested and received stating that there was contact between the eye and the device during cataract surgery.It occurred during the procedure.The procedure was completed the same day.There was no damage and the patient was reported improving post-surgery.
Additional Manufacturer Narrative
Correction: on initial mdr, the method code should be b14 instead of b22 and the h11 should be complaint history and product history records were reviewed and documentation indicated the product met release criteria." additional information has been provided in h.3., h.6., and h.11.The product was not returned for analysis.Only photos were returned and plunger underride was observed on the returned photos.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 returned photos show activated autonome device.The plunger is advanced outside of the nozzle tip and appears to be advanced under the lens.The lens is advanced at the mid nozzle area.The reporter states the use of non-company viscoelastic, which is not qualified to be used with the associated product.Based on our observations of the returned photos, the plunger is advanced outside of the nozzle tip and appears to be advanced under the lens.The lens is advanced at the mid nozzle area.According to the information provided by the customer, the most likely root cause is failure to follow ifu, as the customer states the use of a non-qualified viscoelastic.The use of an unqualified ovd may cause damage to the lens and potential complications during the implantation process.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: 24017366
• Report Number: 9612169-2026-00073
• Device Sequence Number: 13407764
• Product Code: HQL
• UDI-Device Identifier: 00380652393645
• UDI-Public: (01)00380652393645(17)280619(11)250621(10)26051672
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2026

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: CNA0T0
• Device Lot Number: 26051672
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/16/2025
• Supplement Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 03/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: VISCOSUPPRESSANT - VISCOTEC HPMC 20MG/ML.
• Patient Age: 72 YR
• Patient Sex: Male