MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON CLAREON PANOPTIX TORIC TRIFOCAL UV ABSORBING IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	CCWTT5
Medical Device Problem Codes	Product Quality Problem (1506); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Disturbances (2140); Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The sample has not been 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.Associated product information was not provided.It is unknown if a qualified product combination was used.The product investigation could not determine the root cause for the reported complaint of "unspecified issue".The specific "issue" was not clarified by the customer.The explanted lens was not returned for an evaluation.It is unknown if qualified associated products were used.The instructions for use (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.Each lens is subjected to a 100% assessment of the power and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.The company (3.00 cyl.) 18.0 diopter lens was reported to have been explanted in (b)(6) 2025.The replacement lens information was not provided.Information was provided that the bilateral lens had a scheduled explant date of (b)(6) 2025.Due diligence has been performed in an attempt to obtain further information on this event.No additional information has been provided.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A facility representative reported that following an intraocular lens (iol) implant procedure, the iol was exchanged for unspecified lens due to unspecified issue in a secondary procedure.Additional information has been requested.
Additional Manufacturer Narrative
The company (3.00 cyl.) 18.0 diopter (add power +2.17/+3.25 diopter) lens was removed and replaced with a non-company monofocal lens model, 18.0 diopter.Due to the replacement of a multifocal toric lens with a monofocal non-toric lens, and the same diopter, this suggests that the replacement lens (monofocal, non-toric) was an improved selection for this patient's vision needs.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been requested, received and stated the patient had yag (yttrium aluminum garnet) laser prior to explant.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been requested, received and stated the patient had distortion and triple vision.Clinical reason for explant mentioned as other mechanical complication of iol.The lens was exchanged for non-company lens.

• Brand Name: CLAREON PANOPTIX TORIC TRIFOCAL UV ABSORBING IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• 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: 23813751
• Report Number: 1119421-2025-03155
• Device Sequence Number: 18488506
• Product Code: MJP
• UDI-Device Identifier: 00380652458405
• UDI-Public: (01)00380652458405(17)260306(11)220308(10)15363971
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/08/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/06/2026
• Device Model Number: CCWTT5
• Device Catalogue Number: CCWTT5.180
• Device Lot Number: 15363971
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/21/2025
• Supplement Date Received by Manufacturer: 12/23/2025; 05/15/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 01/14/2026; 06/08/2026
• Date Device Manufactured: 03/08/2022
• 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: 59 YR
• Patient Sex: Male