MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON CLAREON TORIC IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	CNW0T4
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Impairment (2138)
Date of Event	07/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility representative reported that following an intraocular lens (iol) implant procedure, the patient experienced blurred vision and clinical reason for explant being astigmatism increased with toric lens.The iol was explanted and exchanged for an unknown advanced technology intraocular lens following the initial implant procedure.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).
Additional Manufacturer Narrative
Based on information received following submission of the initial report, this event does not meet criteria for reporting as a serious injury.No further reports required.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been requested and received stating that unreliability with company calculation formula caused or contributed to the event.Based on this information this event no longer meets reporting criteria per applicable regulation, because it did not directly or indirectly lead, nor was it likely to lead to death or serious deterioration of health, or a serious public health threat.

• Brand Name: CLAREON TORIC IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 246 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 246 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 23321983
• Report Number: 1119421-2025-02707
• Device Sequence Number: 9845545
• Product Code: MJP
• UDI-Device Identifier: 00380652410281
• UDI-Public: (01)00380652410281(17)270118(11)230120(10)15570797
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 12/05/2025

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 Model Number: CNW0T4
• Device Lot Number: 15570797
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/22/2025
• Supplement Date Received by Manufacturer: 11/12/2025
• Initial Report FDA Received Date: 10/17/2025
• Supplement Report FDA Received Date: 12/05/2025
• Date Device Manufactured: 01/20/2023
• 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: ARGOS BIOMETER; MONARCH II LOADING FORCEPS; MONARCH III IOL, CARTRIDGE D; MONARCH III IOL, INJECTOR; PROVISC
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female