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

Model Number	CNWTT0
Medical Device Problem Codes	Failure to Deliver (2338); Inaccurate Delivery (2339)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2025
Type of Reportable Event	Malfunction
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 during an intraocular lens (iol) implant procedure, when the iol was being inserted, the lens did not fully get implanted in the eyes as the lens got stuck midway while advancing.The procedure was completed by using the backup lens.Additional information has been requested.
Additional Manufacturer Narrative
Corrected information provided in h.6., and h.11.Correction: on initial mdr the product code of a140801 was an error.It should have been a140504 on the original mdr.Additional information has been provided in a,1., a.2., a.3.A., b.5., d.10., h.3, h.6., h.11.The product was not returned.A device history 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 device master record were met.A qualified cartridge was indicated.It is unknown of a qualified handpiece and viscoelastic were used.The product investigation could not identify a root cause for the reported complaint.The product was not returned.It is unknown of a qualified handpiece and viscoelastic were used.The ifu instructs: company foldable iols are qualified for use with a company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The ifu instructs that a company qualified delivery system and viscoelastic combination should be used.The use of an unqualified combination may cause damage to the lens and potential complications during the implantation process.The surgeon indicated the issue was not related to the lens.A reason was not provided.New information stated the lens was not stuck in the cartridge.When the surgeon was implanting about 1/8 of the lens got stuck outside the patient¿s eye.The surgeon tried pushing it in, then decided to remove and use a new lens instead.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been requested and received stating that, 1/8 of the lens got stuck outside the patients eye the surgeon tried pushing it in using a non-company manipulator then decided to pull it out instead with a forceps and call out for a new iol as does not want to take the risk of the first iol being scratched on the optic.There was no patient harm.

• 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: 24037464
• Report Number: 1119421-2026-00095
• Device Sequence Number: 10472385
• Product Code: MFK
• UDI-Device Identifier: 00380652408141
• UDI-Public: (01)00380652408141(17)280518(11)240520(10)15862173
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2026

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: CNWTT0.210
• Device Lot Number: 15862173
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/19/2025
• Supplement Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 03/10/2026
• Date Device Manufactured: 05/20/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CLAREON TORIC UV ABSORBING IOL; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; NON-COMPANY MANIPULATOR
• Patient Age: 56 YR
• Patient Sex: Male