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

Model Number	CNW0T6
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	09/26/2025
Type of Reportable Event	Serious Injury
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).
Event or Problem Description
A physician reported that on the first day following an intraocular lens (iol) implant procedure, the patient demonstrated visual acuity was good.Few days later there was a deterioration in vision.Implant axis check showed that the intraocular lens (iol) had rotated from its original implant axis.Repositioning of the iol was planned.Additional information has been received that the repositioning of lens was done, and patient subjective visual outcome was good.
Event or Problem Description
Additional information has been received that axis was stable.
Additional Manufacturer Narrative
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: 23496777
• Report Number: 9612169-2025-02235
• Device Sequence Number: 8965699
• Product Code: MJP
• UDI-Device Identifier: 00380652411035
• UDI-Public: (01)00380652411035(17)280306(11)240308(10)25812398
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CNW0T6
• Device Lot Number: 25812398
• 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: 10/15/2025
• Supplement Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 11/07/2025
• Supplement Report FDA Received Date: 03/02/2026
• 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: OCUCOAT 2% CELLULOSE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male