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

Model Number	CNWTT3
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Visual Disturbances (2140)
Date of Event	10/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A non-healthcare professional reported that during an intraocular lens (iol) implant procedure, the lens was explanted with an unspecified issue.Additional information was received stating the patient had refractive lens exchange (rle) for the left eye (os).The patient needed iol rotation and experienced glare and a dark area on the periphery, also noticing a difference between the left eye and the right eye after surgery in the right eye.The patient tried a contact lens trial but still had shadows os.In the surgeon's opinion, the product had caused or contributed to the event.The iol was exchanged for a different model and different diopter of the same company lens 1 month and 13 days after the initial implant procedure.There was no further impact to the patient, and the patient's issues were resolved.
Additional Manufacturer Narrative
The lens was returned for evaluation.Solution is dried on the lens.The lens is cut in half, typical of insertion and removal from the eye.Both halves are adhered to each other by solution.No other damage is observed.A power and resolution inspection could not be conducted due to extensive 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.Associated products were not provided.It is unknown if qualified products were used.The product investigation could not identify a root cause for the reported complaint.Lens damage was observed.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.Information was provided that the company (1.50), 22.5 diopter (add power +2.17/+3.25) lens was replaced with a company, 23.0 diopter (add power +2.17/+3.25) lens.Due to the exchange of a multifocal toric lens to a multifocal lens may suggest that the replacement lens model was an improved choice for the patient's vision needs.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON PANOPTIX TORIC TRIFOCAL HYDROPHOBIC 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: 23748086
• Report Number: 1119421-2025-03102
• Device Sequence Number: 13157724
• Product Code: MJP
• UDI-Device Identifier: 00380652468589
• UDI-Public: (01)00380652468589(17)281020(11)241022(10)15938758
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/08/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: CNWTT3
• Device Catalogue Number: CNWTT3.225
• Device Lot Number: 15938758
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2024
• 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: UNKNOWN CARTRIDGE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female