MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON TORIC ASPHERIC HYDROPHOBIC ACRYLIC IOL WITH AUTONOME DELIVERY SYSTEM; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	CNA0T3
Medical Device Problem Codes	Failure to Fold (1255); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2025
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 injector did not catch the edge of the optic and went under the iol not initiating the folding.The procedure was completed by using the backup lens.There was no patient impact.
Additional Manufacturer Narrative
Additional information has been provided in h.3., h.6., h.11.The product was not returned for analysis.Only photo was returned.The trailing haptic was observed to be stuck/caught in the nozzle tip on the returned photo.The returned photo shows an activated company device.The plunger is advanced outside the tip of the nozzle.Part of the iol and one haptic is advanced outside the nozzle tip.The trailing haptic and part of the optic appears to be stuck at the tip of the nozzle.The complainant indicates the use of healon as a viscoelastic which is not qualified for use with the associated product.We are unable to determine the root cause for the reported complaint lens pusher went under the lens.The product was not returned for analysis.The trailing haptic was observed to be stuck/caught in the nozzle tip on the returned photo.While we are unable to determine the origin of the reported complaint, our observations reasonably suggest that it is not manufacturing related.Based on the information provided by the customer, the most likely root cause is failure to follow ifu, as the surgeon states the use of non-qualified combination.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).

• Brand Name: CLAREON TORIC ASPHERIC HYDROPHOBIC ACRYLIC IOL WITH AUTONOME DELIVERY SYSTEM
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• 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: 23631062
• Report Number: 9612169-2025-02339
• Device Sequence Number: 15798188
• Product Code: MJP
• UDI-Device Identifier: 00380652398794
• UDI-Public: (01)00380652398794(17)290217(11)250219(10)25988523
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• 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: CNA0T3
• Device Lot Number: 25988523
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/29/2025
• Supplement Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 02/16/2026
• Date Device Manufactured: 02/19/2025
• 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: HEALON
• Patient Sex: Unknown