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	Insufficient Information (4580)
Date of Event	12/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A non-healthcare professional reported that during an intraocular lens (iol) implant procedure, the lens was defective, when the injector was inserted into the eye, and that's where the solution did not come out.The surgery was completed the same day.The patient was recovering.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
Additional information provided in b.5., d.9., h.3., h.6.And h.11.The product was not returned for analysis.Only photos were returned.The reported complaint was not 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.Photos provided show an company device.The lockout assembly has been removed.The nozzle has been removed from the device.The plunger appears to be advanced outside the nozzle tip.The iol is visible on a piece of surgical gauze.The complainant indicates the use of non-company as a viscoelastic which is not qualified for use with the associated product.The reported complaint cannot be confirmed from the provided photos, however, based on the information provided by the customer, the most likely root cause is failure to follow (instructions for use) ifu, as the surgeon states the use of non-qualified viscoelastic.The use of an unqualified combination may cause damage to the iol 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).
Event or Problem Description
Additional information has been received that the lens did not came out of injector.The lens removed manually and the iol was ruled out because it was damaged during extraction.

• 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: 24147890
• Report Number: 9612169-2026-00174
• Device Sequence Number: 15663722
• Product Code: HQL
• UDI-Device Identifier: 00380652393775
• UDI-Public: (01)00380652393775(17)280610(11)250612(10)26051964
• 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): 02/16/2026

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: 26051964
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/31/2025
• Supplement Date Received by Manufacturer: 01/25/2026
• Initial Report FDA Received Date: 01/22/2026
• Supplement Report FDA Received Date: 02/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2025
• 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: VISCOTEC HPMC 20MG/ML.
• Patient Age: 76 YR
• Patient Sex: Male