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

Model Number	CNWTT0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	12/23/2024
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 surgeon reported that following an intraocular lens (iol) implant procedure, the patient experienced visual acuity after surgery was poor due to intolerance.The iol was exchanged for unspecified single focus model lens 3 weeks 3 days following the initial implant procedure.Additional information has been requested.
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.A small crack is observed near the edge of the optic.A power and resolution inspection could not be conducted due to extensive damage.Product history records were reviewed, and the documentation indicated the product met release criteria.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.A power and resolution inspection could not be conducted due to extensive damage.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 company, 08.5 diopter (add power +2.2/+3.2) lens was replaced with an unspecified monofocal lens.Due to the exchange of a multifocal lens to a monofocal lens, this 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 TRIFOCAL HYDROPHOBIC INTRAOCULAR LENS
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• 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: 21534866
• Report Number: 1119421-2025-00599
• Device Sequence Number: 8050266
• Product Code: MFK
• UDI-Device Identifier: 00380652407892
• UDI-Public: (01)00380652407892(17)280212(11)240214(10)15802969
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2025

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: CNWTT0
• Device Catalogue Number: CNWTT0.085
• Device Lot Number: 15802969
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2025
• Supplement Date Received by Manufacturer: 04/14/2025
• Initial Report FDA Received Date: 03/06/2025
• Supplement Report FDA Received Date: 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown