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

Model Number	CCWTT3
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Disturbances (2140)
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 the intraocular lens (iol) implant procedure, patient had light sensitivity, decreased near vision, glare and diminished vision.The lens was exchanged with an unknown advanced technology intraocular lens (atiol) after the initial implant procedure.The clinical reason for explantation was mechanical complications of the iol.Additional information received stating that the lens was exchanged with non-company lens.In the surgeon¿s opinion mechanical defect of iol contributed to the event.
Additional Manufacturer Narrative
The lens was returned adhered to a steam indicator strip inside a sealed noncompany blue pouch.One haptic was bent in the distal are in dried viscoelastic.The lens was cleaned with klrp for further evaluation.The lens released from the paper.Dark ink transferred from the paper strip to the posterior of optic.Recleaned the lens with klrp.The transferred ink was removed.The bent haptic relaxed into the original position.No damage was observed to the lens.A dimensional inspection (plan view) was conducted.The lens was within the specification per the approved template.Product history records were reviewed, and the documentation indicated the product met release criteria.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 (sphere and cylinder) and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.The lens was retested and verified by an engineering technician for power (sphere and cylinder) and optical resolution.The lens met specification for a company (1.50 cyl.) 22.5 diopter (add power +2.2/+3.2 diopter) lens.The multifocal toric company (1.50 cyl.) 22.5 diopter (add power +2.2/+3.2 diopter) was removed and replaced with a non-toric enhanced monofocal lens design, 22.5 diopter.Due to the exchange of a multifocal toric 22.5 diopter lens for a monofocal toric 22.5 diopter lens, this suggests that a non-toric enhanced monofocal lens design as the replacement lens may have been an improved choice for the patient's vision needs.File will be reopened if new information is received.The manufacturer internal reference number is: (b)(4).

• 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: 21582470
• Report Number: 1119421-2025-00656
• Device Sequence Number: 13080396
• Product Code: MJP
• UDI-Device Identifier: 00380652457439
• UDI-Public: (01)00380652457439(17)260419(11)220421(10)15392846
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 04/21/2025

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 Expiration Date: 04/19/2026
• Device Model Number: CCWTT3
• Device Catalogue Number: CCWTT3.225
• Device Lot Number: 15392846
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/10/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/12/2025
• Supplement Date Received by Manufacturer: 03/24/2025
• Initial Report FDA Received Date: 03/12/2025
• Supplement Report FDA Received Date: 04/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2022
• 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 III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; ORA SYSTEM WITH VERIFEYE MESSAGING; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE; UNKNOWN IMPLANTATION/FOLDING FORCEPS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown