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 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 non-healthcare professional reported that following an intraocular lens (iol) implant procedure,lens was explanted at secondary procedure due to patient experienced unable to tolerate dysphotopsia.The iol was replaced with monofocal iol approximately two month after initial procedure.Additional information was requested.
Additional Manufacturer Narrative
Correction information was provided in h.11.Upon further review of the available information, iol was exchanged for the different model, same company lens but half a diopter less power indicating the correct lens power was not implanted initially.There is no reported defect or fault with the iol.Hence this event does not meet criteria for reporting as a serious injury.No further reports required.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; 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: 21027190
• Report Number: 1119421-2024-02635
• Device Sequence Number: 8310687
• Product Code: MFK
• UDI-Device Identifier: 00380652408158
• UDI-Public: (01)00380652408158(17)280512(11)240514(10)15855610
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: 2024
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2025

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: CNWTT0.215
• Device Lot Number: 15855610
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/02/2024
• Supplement Date Received by Manufacturer: 02/21/2025
• Initial Report FDA Received Date: 12/27/2024
• Supplement Report FDA Received Date: 02/27/2025
• Date Device Manufactured: 05/14/2024
• 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