MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON TORIC IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	CNW0T4
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A health care professional reported that during the implantation of the iol (intraocular lens), while implanting, it was observed that the optic-haptic positioning marks were decentered.Surgery was completed on the same day and the lens was left implanted.Additional information was received and it states that had a mismatch between the toricity markings and the haptics (they are aligned by design).They followed up with the patient postoperatively, and it appeared that the toricity was effective.To continue the procedure without removing the lens, despite this very significant mismatch between the iol (intraocular lens) toricity marking and the haptics and postoperatively the patient appeared to have the correct astigmatic help from the toric lens.
Additional Manufacturer Narrative
The product was not returned for analysis; the lens remains implanted.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).

• Brand Name: CLAREON TORIC IOL
• 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: 24661178
• Report Number: 9612169-2026-00632
• Device Sequence Number: 9198254
• Product Code: MJP
• UDI-Device Identifier: 00380652410250
• UDI-Public: (01)00380652410250(17)280306(11)240308(10)25812297
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2026

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: CNW0T4
• Device Lot Number: 25812297
• 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: 02/26/2026
• Supplement Date Received by Manufacturer: 05/14/2026
• Initial Report FDA Received Date: 03/23/2026
• Supplement Report FDA Received Date: 06/08/2026
• Date Device Manufactured: 03/08/2024
• 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: METHYLCELLULOSE 2%; MONARCH III IOL, CARTRIDGE D; MONARCH III IOL, INJECTOR; VISCOAT
• Patient Sex: Unknown