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 Codes	Blurred Vision (2137); Visual Impairment (2138)
Type of Reportable Event	Serious Injury
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, patient unable to see anything up close.The lens was exchanged with non-company lens after the initial implant procedure.Clinical reason for explant is +0.40 d myopic miss.Additional information received stating that patient¿s issue resolved.
Additional Manufacturer Narrative
Additional information was provided in d9, h.3., h.6.And h.11.The lens was returned on a triangular piece of small, white medical sponge material placed into a plastic bag.Viscoelastic and blood was dried on the lens.One haptic was bent in gusset area with the distal area folded toward the optic edge.The optic was cut into two pieces, typical in appearance to an insertion and removal.The lens was cleaned with klrp to further evaluate.The bent haptic relaxed into the original position.One optic portion has lines of cracked damage on the anterior and posterior optic surfaces in the shape of an instrument used to grasp the lens.The power and resolution of the returned lens could not be rechecked due to being returned cut into pieces.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 and handpiece were used with a non-qualified viscoelastic.The product investigation could not determine the root cause for the reported complaint of "unable to see anything up close".The clinical reason provided for the complaint was due to +0.40 d myopic miss.The product was returned cut into pieces, typical of insertion and removal.Each lens is subjected to a 100 percent 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 (1.50 cyl.) 20.5 diopter (1.5 extended depth of focus) lens was removed and replaced with a 21.0 diopter noncompany toric lens.Due to the exchange of the multifocal toric 20.5 diopter lens for a noncompany toric lens that was a half diopter larger may suggest that the half diopter larger power was an improved selection for this 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: 22750722
• Report Number: 1119421-2025-02213
• Device Sequence Number: 9672881
• Product Code: MJP
• UDI-Device Identifier: 00380652455299
• UDI-Public: (01)00380652455299(17)280309(11)240311(10)15815447
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 10/07/2025

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: CCWET3
• Device Lot Number: 15815447
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/16/2025
• Supplement Date Received by Manufacturer: 09/15/2025
• Initial Report FDA Received Date: 08/08/2025
• Supplement Report FDA Received Date: 10/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2024
• 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 III IOL DELIVERY SYSTEM, CARTRIDGE C.; MONARCH III IOL DELIVERY SYSTEM, INJECTOR.; OCUCOAT VISCOELASTIC.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male