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

Model Number	CCWTT4
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	02/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information was provided in d.9., h.3., h.6.And h.11.The lens was returned inside a on a surgical sponge.Solution was dried on the lens.The lens was cut into pieces, typical of insertion and removal.Power and resolution testing could not be conducted due to the extensive optic damage.Product history records were reviewed and documentation indicated the product met release criteria.Qualified associated products were indicated.Based on the information provided, the event does not appear to be related to the product.The company diopter (2.25cyl), add power +2.2 & 3.2 lens model was replaced with a company diopter (1.50cyl), add power +2.2 & 3.2 lens model.An iol (intraocular lens) exchange for a difference equal to or greater than two diopters, indicates the event is most likely related to a calculation error.In this case, a 2.5 diopter higher power iol was selected.The exchange for a 2.5 higher diopter lens model and the difference in cylinder between the original implant lens model and the replacement lens model (company to company) may suggest that the replacement lens model was an improved choice for the patient's vision needs.Each lens is subjected to a 100% 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.The manufacturer internal reference number is: (b)(4).
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 facility representative reported that following an intraocular lens (iol) implant procedure, explanted iol with reason blurry vision.Clinical reason for the explant is off target.Replaced with 24.0 d lens with more than 2 diopter difference different model lens.Additional information was requested.

• Brand Name: CLAREON PANOPTIX TORIC TRIFOCAL 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: 21695590
• Report Number: 1119421-2025-00835
• Device Sequence Number: 8849966
• Product Code: MJP
• UDI-Device Identifier: 00380652457941
• UDI-Public: (01)00380652457941(17)261026(11)221028(10)15516391
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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): 05/05/2025

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: CCWTT4
• Device Catalogue Number: CCWTT4.215
• Device Lot Number: 15516391
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/25/2025
• Supplement Date Received by Manufacturer: 04/09/2025
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 05/05/2025
• Date Device Manufactured: 10/28/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CLAREON VIVITY TORIC EXT; DUOVISC VISCOELASTIC SYSTEM; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female