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

Model Number	CNWTT0
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information provided in h.3., h.6.And h.11.The product was not returned.A ten-second video was provided.The video started with the lens already implanted.The trailing haptic was extended outside of the eye through the incision.Viscoelastic was observed on the haptic.The haptic end was manipulated with a metal instrument.There appeared to be the end of a broken haptic adhered to the bottom of the extended trailing haptic.The viscoelastic and length of the video made it difficult determine details.A photo was also provided.The photo showed a piece of a broken haptic on a lens case base.The portion was broken-gusset and distal area.A batch 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 medical device file were met.Associated products were not provided.The root cause for the reported event was determined to be potentially manufacturing related.The lens remains implanted.Based on review of the provided photo and video and piece of a broken haptic was adhere to the trailing haptic after the lens was loaded and delivered.All lenses are 100% inspected for cosmetic attributes and the additional piece of broken haptic exhibited in the video and photo would not have met company¿s release criteria.The complaint was reviewed with the appropriate department supervisor and inspection personnel.The investigation has been completed based on current information.Receipt of additional relevant information or supporting materials will prompt a re-evaluation of the complaint investigation.Complaints are reviewed and monitored for adverse trends on a monthly basis.No adverse trends have been observed associated with the reported product and event.No further action has been identified for this reported event.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.No further action is warranted at this time.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: 50158483
• Report Number: 1119421-2026-01635
• Device Sequence Number: 10602630
• Product Code: MFK
• UDI-Device Identifier: 00380652408202
• UDI-Public: (01)00380652408202(17)290531(11)250602(10)16045782
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CNWTT0
• Device Catalogue Number: CNWTT0.240
• Device Lot Number: 16045782
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/16/2026
• Supplement Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 08/06/2026
• Supplement Report FDA Received Date: 09/28/2026
• Date Device Manufactured: 06/02/2025
• 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
• Patient Sex: Unknown