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

Model Number	CCWET0
Medical Device Problem Code	Use of Incorrect Control/Treatment Settings (1126)
Health Effect - Clinical Codes	Nausea (1970); Dizziness (2194)
Date of Event	09/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility representative reported following an intraocular lens (iol) implant procedure, the patient can't tolerate dizziness and nausea.The lens was explanted and replaced with company lens in a secondary procedure.The clinical reason for the explant was goal plano, got plano.Additional information was requested.
Additional Manufacturer Narrative
The lens was returned inside a clear plastic bag with a piece of white medical sponge material.Solution was dried on the lens.The optic was cut into two pieces.One optic portion edge was torn and split in two separate areas.The other optic portion was cracked near the optic edge.A power (cylinder and sphere) and resolution recheck could not be conducted due to the lens 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.A qualified cartridge, handpiece and viscoelastic were used.The root cause cannot be determined for the reported complaint.The lens was cut into two pieces, typical of an insertion and removal.Additional lens damage was observed.Each lens was subjected to a 100% assessment of the power 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 optic damage.The company model 22.0 diopter (1.5 extended depth of focus) lens was removed and replaced with a company model 21.5 lens.Due to the exchange of a vivity edof (extended depth of focus) company model 22.0 diopter lens for a monofocal lens that was also one-half diopter less may suggest that the replacement lens was an improved selection for this patient's vision needs.Information was provided on the completed questionnaire that in the surgeon's opinion, the cause of the event was "due to previous lasik".The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON VIVITY EXTENDED VISION UV ABSORBING IOL
• Common Device Name: EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS
• 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: 23896159
• Report Number: 1119421-2025-03240
• Device Sequence Number: 4619373
• Product Code: POE
• UDI-Device Identifier: 00380652405812
• UDI-Public: (01)00380652405812(17)261129(11)221201(10)15541038
• 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: 2024
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/26/2025

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: CCWET0
• Device Lot Number: 15541038
• 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: 12/26/2025
• Date Device Manufactured: 12/01/2022
• 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; PROVISC OVD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown