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	Visual Impairment (2138)
Date of Event	10/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A nonhealthcare professional reported via medical record that following an intraocular lens (iol) implant procedure, the patient experienced residual refraction error and astigmatism due to lens misalignment or displacement.Patient also experienced the vitreous floaters.The lens was explanted and exchanged with same model company lens to optimize the outcome.Additional information has been requested.
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
Additional information has been requested and received stating there was no injury to the patient.
Additional Manufacturer Narrative
Correction information provided in b.3., b.5., b.6.And d.10.And h.11.The manufacturer internal reference number is: (b)(4).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.

• 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: 23521337
• Report Number: 9612169-2025-02250
• Device Sequence Number: 9704952
• Product Code: MJP
• UDI-Device Identifier: 00380652411097
• UDI-Public: (01)00380652411097(17)270626(11)230628(10)25668647
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2025

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: 25668647
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/16/2025
• Supplement Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 11/11/2025
• Supplement Report FDA Received Date: 12/12/2025
• Date Device Manufactured: 06/28/2023
• 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: ANTIBIOTIC EYE DROPS.; CLAREON MONARCH IV INJECTOR.; MONARCH II FORCEPS.; MONARCH III CARTRIDGE D.; ORA SYSTEM.; PROVISC.; SINSKEY HOOK AND FORCEPS.; UNSPECIFIED VISCOELASTIC.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female