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

Model Number	CNA0T4
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	12/19/2025
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 healthcare professional reported that during an intraocular lens (iol) implant procedure, trailing haptic was folded.Additional information was received by stating, there was no patient contact.
Additional Manufacturer Narrative
Additional information has been provided in d.9., h.3., h.6., and h.11.The product was returned for analysis, and the reported complaint was observed.The device was received loose in the product carton.Solution is dried in the device.The lock-out assembly has been removed.The plunger has been advanced into the mid-nozzle.The iol (intraocular lens) has been advanced into the depth guard and is damaged.The trailing haptic is twisted and bent/deformed.The reporter stated the use of "viscoelastic: combivisc", which is not qualified to be used with the associated product.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 (intraocular lens), as the customer states the use of non-qualified viscoelastic.The use of an unqualified ovd (ophthalmic viscosurgical device) 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 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: 24018470
• Report Number: 9612169-2026-00079
• Device Sequence Number: 9136811
• Product Code: MJP
• UDI-Device Identifier: 00380652399265
• UDI-Public: (01)00380652399265(17)280922(11)240924(10)25921200
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2026

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: CNA0T4
• Device Lot Number: 25921200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/18/2025
• Supplement Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2024
• 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: VISCOELASTIC: COMBIVISC.
• Patient Sex: Unknown