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

Model Number	CCW0T3
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A product was not returned for analysis as it was discarded.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 during intraocular lens (iol) implant procedure, the surgeon reported that there were marks on toric intraocular lens are not lined up with each other.It was also reported that the marks were about 30 degrees off from one another and superior mark was lined up as expected at or around haptic, inferior mark was about 30 degrees off and described as "gapped out".It was stated that the second lens was opened and the marks were lined up as expected.The lens was cut out and replaced with the backup lens to complete the surgery.The procedure was completed on same day without any harm to the patient.
Additional Manufacturer Narrative
Additional information was provided in h.3., h.6.And h.11.The product was not returned.A photo was provided of the implanted lens.One set of axis marks were visible.The marks were slightly misaligned.A product history record review and a non-conformance review of the reported lot number was conducted.No deviations, were identified and all corresponding production release specifications defined in the device master record were met.The product was not returned.A photo was provided of the implanted lens.One set of axis marks were visible.The marks were slightly misaligned.The root cause for the observed misalignment was 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 percent 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.A corrective action preventive action was put in place to remove the ability for operators to manually adjust the mill path.Parts will be rejected if the mill cannot align the wafer.The product for this file was manufactured before the corrective action preventive action was in put in place.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: 22203208
• Report Number: 1119421-2025-01655
• Device Sequence Number: 20554701
• Product Code: MJP
• UDI-Device Identifier: 00380652431842
• UDI-Public: (01)00380652431842(17)281026(11)241028(10)15940400
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2025

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: CCW0T3
• Device Lot Number: 15940400
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/20/2025
• Supplement Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 06/13/2025
• Supplement Report FDA Received Date: 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/28/2024
• 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: DUOVISC.; KELMAN MCPHERSON FORCEPS.; MONARCH III CARTRIDGE D.; MONARCH III INJECTOR.
• Patient Age: 71 YR
• Patient Sex: Male