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

Model Number	CCW0T3
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Disturbances (2140)
Date of Event	02/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information has been provided in d.9.,h.3., h.6., and h.11.Only a portion of the lens which contained a haptic was returned in a plastic bag.Solution was dried on the lens.The optic was cut into portions, typical of insertion and removal.The other cut portions of the optic and other haptic were not returned for evaluation.The power and resolution of the returned lens could not be re-evaluated due to the extensive optic damage.Product history records were reviewed and documentation indicated the product met release criteria.The file indicated the use of associated products.However, they are not relevant to the reported complaint.The product investigation could not identify a root cause for the reported complaint.Each lens is subjected to a 100 percent assessment of the power (spherical and cylinder) and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.The power and resolution of the returned lens could not be re-evaluated due to the extensive optic damage.Information was provided that in the surgeon¿s opinion, the product did not cause or contribute to the event.In the surgeon¿s opinion the event was caused by patient dissatisfaction/ positive dysphotopsia.The toric company (1.50cyl), 19.0 diopter, (1.5 extended depth of focus) lens model was replaced with an unknown monofocal lens (replacement lens model and diopter were not provided).No further information has been provided at this time.The file will be reopened and updated if new information is received.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non healthcare professional reported that, after intraocular lens implantation surgery, the patient was unhappy with positive dysphotopsia.Hence the lens was explanted and replaced with another unknown monofocal lens in a secondary procedure.The clinical reason for explant was positive dysphotopsia and there was no patient impact was reported.Additional information has been requested.
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON TORIC UV ABSORBING 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: 22051790
• Report Number: 1119421-2025-01435
• Device Sequence Number: 18367410
• Product Code: MJP
• UDI-Device Identifier: 00380652431811
• UDI-Public: (01)00380652431811(17)270529(11)230531(10)15646179
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2025

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: CCW0T3
• Device Lot Number: 15646179
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2025
• Supplement Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 05/20/2025
• Supplement Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2023
• 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: CLAREON MONARCH IV IOL, INJECTOR; DUOVISC; MONARCH II LOADING FORCEPS; MONARCH III IOL, CARTRIDGE D; ORA SYSTEM WITH VERIFEYE MESSAGING, CART
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male