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

Model Number	CNW0T3
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blurred Vision (2137)
Type of Reportable Event	Serious Injury
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 nurse reported that following intraocular lens (iol) implant procedure, patient had blurred vision.The lens was exchanged for an unknown advanced technology intraocular lens (atiol) after the initial implant procedure.
Additional Manufacturer Narrative
Additional information was provided in a3.A, and b5.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information received stating that, the physician stated that this patient was unable to tolerate monovision and that's why lens was exchanged, and patient had no other problems to report.There was no problem with the lens itself.
Additional Manufacturer Narrative
Additional information was provided in h.3., h.6.And h.11.The product was not returned for analysis.Additional information: "the physician stated that this patient was unable to tolerate monovision and that is why lens was exchanged and had no other problems to report.No problem with the lens itself".The root cause for the reported complaint appears to be a coincidental event that was unrelated to the product as user facility reported that "this patient was unable to tolerate monovision and that is why lens was exchanged and had no other problems to report.No problem with the lens itself".Based on this information, the product did not cause/contribute to the event.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 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: 22993745
• Report Number: 9612169-2025-01783
• Device Sequence Number: 15682076
• Product Code: MJP
• UDI-Device Identifier: 00380652409506
• UDI-Public: (01)00380652409506(17)260503(11)220505(10)25399413
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/08/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/03/2026
• Device Model Number: CNW0T3
• Device Lot Number: 25399413
• 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: 08/19/2025
• Supplement Date Received by Manufacturer: 09/09/2025; 11/14/2025
• Initial Report FDA Received Date: 09/08/2025
• Supplement Report FDA Received Date: 09/30/2025; 12/08/2025
• Date Device Manufactured: 05/05/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female