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	Insufficient Information (4580)
Date of Event	01/07/2026
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 during intraocular lens (iol) implant procedure, the surgeon noticed that one of the implant legs (haptic) didn't unfold properly in the cartridge.They tried inserting lens into another cartridge, but that didn't change anything.The implant was discarded.Additional information was requested and received stating that unspecified replacement lens was used.The procedure was completed on the same day.
Additional Manufacturer Narrative
Additional information was provided in h.3., h.6., and h.11.The product was not returned for analysis.The reporter states the use of "non-company " as a viscoelastic, which is not qualified to be used with the associated product.The reported complaint was not observed as no sample was returned for analysis; however, based on the information provided by the customer, the most likely root cause is failure to follow ifu (instructions for use), 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.In addition to the above, it is stated in the file that "they tried inserting it into another cartridge, but that didn¿t change anything"; company specific is a pre-loaded device, and the lens must not be removed from it and reloaded into a cartridge and can only be used with the company specific 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 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: 24221310
• Report Number: 9612169-2026-00204
• Device Sequence Number: 8197404
• Product Code: MJP
• UDI-Device Identifier: 00380652399395
• UDI-Public: (01)00380652399395(17)281217(11)241219(10)25955895
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2026

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: 25955895
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/09/2026
• Supplement Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 01/30/2026
• Supplement Report FDA Received Date: 03/11/2026
• Date Device Manufactured: 12/19/2024
• 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: MONARCH IOL DELIVERY SYSTEM, INJECTOR, UNSPECIFIED.; UNSPECIFIED CARTRIDGE.; VISTHESIA FROM ZEISS.
• Patient Sex: Unknown