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

Model Number	CCWET3
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	06/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A non healthcare professional reported that, after intraocular lens implantation surgery, the patient experienced refractive myopia and cylinder.Hence the lens was explanted and replaced with another lens in a secondary procedure.Additionally the patient had yag (yttrium aluminum garnet) laser surgery.Patient issues was resolved and in the surgeon prognosis the patient condition was good.There was no further impact to the patient.Additional information has been requested.
Additional Manufacturer Narrative
The lens was returned in a plastic bag with a surgical sponge.Solution was dried on the lens.The optic was cut from edge past center, typical of insertion and removal.The lens had multiple small areas of starburst damage observed in the lens material of the optic, typical of damage caused by a yag laser procedure conducted post implantation.Power and resolution of the returned lens could not be conducted due to the extensive optic damage.A device history record review and a non-conformance review of the reported lot number was conducted.The deviation review did not reveal any potential contributing factors to the reported complaint and all corresponding production release specifications defined in the device master record were met.Qualified associated products were indicated.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.The file indicated that the company (1.50cyl), 20.5 diopter lens model was replaced with a company (1.50cyl), 19.0 diopter lens model.Information was provided that in the surgeon's opinion; the lens did not cause or contribute to the event.In the surgeon's opinion residual myopia and cylinder caused the event.Due to the exchange of the toric company (1.50cyl), 20.5 diopter lens for the same toric lens model company (1.50cyl) would suggest that there was no issue with the choice of cylinder of the lens for this patient.The 1.5 lower diopter difference for the replacement lens may suggest that the replacement lens lower diopter may have been an improved choice for the patient's vision needs.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON VIVITY TORIC EXTENDED VISION 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: 23941827
• Report Number: 1119421-2026-00004
• Device Sequence Number: 12749260
• Product Code: MJP
• UDI-Device Identifier: 00380652455299
• UDI-Public: (01)00380652455299(17)260117(11)220119(10)15338672
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/02/2026

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: 01/17/2026
• Device Model Number: CCWET3
• Device Lot Number: 15338672
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 01/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2022
• 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: MONARCH II IOL, CARTRIDGE B.; MONARCH III IOL, INJECTOR.; ORA SYSTEM.; PROVISC.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male