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

Model Number	CCW0T6
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/13/2026
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 physician reported that during an intraocular lens (iol) implant procedure, they had a strange occurrence when they put an company toric lens in, the 3 dots on each side did not line up at all with the haptic junction.They were almost 90 degrees away (but not exactly).The physician didn¿t want to put the patient through an unnecessary exchange, so they lined everything up by trusting the 3 dots on each side and ignoring where the actual haptic junction was.They had never seen this before.Additional information was received by stating, the patient seemed to be doing fine.Even though the toric markings were grossly away from the haptic junction, the surgeon aligned to the markings, ignoring the junction position, and the patient continued to do well.It was clearly a manufacturing error.
Additional Manufacturer Narrative
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.The lens remains implanted.The reported issue could not be verified.However, the root cause for the reported misalignment of the axis marks would be manufacturing related.A contributing factor to this event was that the milling equipment allowed the milling operator to manually select the mill orientation when the vision system could not identify the fill holes on the wafer.The toric axis mark misalignment was determined to be a cosmetic issue only, with no functional impact.The toric axis is aligned with the toric axis marks and is set by the molding process.Each lens is subjected to a 100% assessment of the power (spherical and cylinder) and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.The ifu (instructions for use) instructs precisely align the axis marking indentations on the toric iol (intraocular lens) with the marked intended axis of lens placement.Information was provided that the surgeon aligned to the markings, ignoring the junction position.The patient is doing well.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON TORIC 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: 24322089
• Report Number: 1119421-2026-00297
• Device Sequence Number: 9931114
• Product Code: MJP
• UDI-Device Identifier: 00380652435147
• UDI-Public: (01)00380652435147(17)270205(11)230207(10)15577224
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2026

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: CCW0T6
• Device Catalogue Number: CCW0T6.265
• Device Lot Number: 15577224
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/21/2026
• Supplement Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 02/12/2026
• Supplement Report FDA Received Date: 03/16/2026
• Date Device Manufactured: 02/07/2023
• 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