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

Model Number	CNWTT0
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Data Problem (3196)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Impairment (2138)
Date of Event	12/09/2024
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 physician reported that, the patient experienced less vision and refractive outcome of patient was reported as 1.25 diopters hypermetropic.So, intraocular lens (iol) was explanted in the secondary implant procedure.Additional information received and it states that the corneal topography, both pre- and post-operation, do not show any strange images that could explained that the vision or outcome can change.The doctor has performed an iol exchange od (right eye) and now has a good outcome.Based on the od outcome.Doctor has adjusted the iol strength os (left eye), this has now also come out well.
Additional Manufacturer Narrative
The lens was returned in a lens case for the replacement lens case.Viscoelastic was dried on the lens.The lens was cut into two pieces across the center, typical of removal.Power and resolution could not be reverified due to the optic damage.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.The root cause could not be determined for the reported refractive error.The lens power could not be reverified due to the optic 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 lens was returned in the lens case for the replacement lens.The company, 23.0 diopter lens was replaced with a company, 24.5 diopter lens.As the reported refractive surprise was indicated to be 1.25, and the replacement lens was 1.5 diopters different, this may indicate a calculation issue.File will be reopened if new information is received.Based on information received following submission of the initial report, this event does not meet criteria for reporting as a serious injury.No further reports required.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information received and it states that explantation happened 1 week after the first surgery.Additional information received and reported that the iol was exchanged for the same lens model but one and half a diopter more power indicating the correct lens power was not implanted initially.There is no reported defect or fault with the iol.

• Brand Name: CLAREON PANOPTIX TRIFOCAL HYDROPHOBIC INTRAOCULAR LENS
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 21065973
• Report Number: 1119421-2025-00035
• Device Sequence Number: 3418134
• Product Code: MFK
• UDI-Device Identifier: 00380652408189
• UDI-Public: (01)00380652408189(17)280211(11)240213(10)15796068
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2025

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: CNWTT0.230
• Device Lot Number: 15796068
• 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: 12/10/2024
• Supplement Date Received by Manufacturer: 02/06/2025
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 03/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2024
• 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 Age: 60 YR
• Patient Sex: Male