MAUDE Adverse Event Report: Alcon Research, LLC - Huntington Clareon PanOptix Trifocal Hydrophobic Intraocular Lens; Lens, Multifocal Intraocular

Model Number	CNWTT0
Medical Device Problem Codes	Break (1069); Failure to Unfold or Unwrap (1669); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	08/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A nurse reported that during the presbyopic lens exchange surgery, the lens did not unfold well.No damage was observed on the lens during handling.The haptic was moderately folded in a different position, which was not uncommon.After implantation and unfolding of the iol, due to the final positioning, the surgeon noted that the anterior haptic to detach from its original location and the haptic adhered to the optic.Hence the lens was explanted during the same procedure and the corneal suture was performed.This caused the surgery to prolong and increased the endothelial stress.The corneal suture led to surgically induced astigmatism.The procedure was completed on the same day.
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).

• 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 ; +1(800)757-9780
• MDR Report Key: 50473473
• Report Number: 1119421-2026-01770
• Device Sequence Number: 10112326
• Product Code: MFK
• UDI-Device Identifier: 00380652408141
• UDI-Public: (01)00380652408141(17)290628(11)250630(10)16060414
• Combination Product (Y/N): N
• Initial Reporter Country: LO
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/27/2026

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: CNWTT0
• Device Catalogue Number: CNWTT0.210
• Device Lot Number: 16060414
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/04/2026
• Initial Report FDA Received Date: 08/27/2026
• Date Device Manufactured: 06/30/2025
• 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 Cartridge D.; PROVISC Ophthalmic ViscoSurgical Device.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown