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

Model Number	CNW0T3
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A non-healthcare professional reported that during an intraocular lens (iol) implant procedure, toric markers not aligned with haptic / toric markers on lens for placement were not in the correct area.The surgeon explanted and implanted company another same model toric lens.In the surgeon¿s opinion product contributed to event.There was no patient harm.
Additional Manufacturer Narrative
The lens was returned positioned incorrectly (posterior surface up) in a lens case inside a biohazard bag.Viscoelastic was dried on the lens.One haptic was broken in the distal, returned outside the well area of the lens case.The other haptic was broken in the haptic/optic junction and broken in the gusset area.Both broken portions of this haptic were also returned.The optic displayed one set of toric axis marks.The toric axis marks were misaligned/shifted.The axis marks were located at the 3 o'clock and 9 o'clock positions of the optic.The lens was cleaned with klrp to remove the dried viscoelastic and further evaluate the lens.The optic was scratched near the anterior optic center.The posterior optic has a large cracked and split area between the optic center and one haptic.Photos were also provided that displayed broken haptic damage.The toric axis marks could not be observed in the photo due to the poor quality of the photo.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.All indicated associated products were qualified for use with this lens.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% 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 manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON TORIC 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: 23796882
• Report Number: 1119421-2025-03144
• Device Sequence Number: 5520725
• Product Code: MJP
• UDI-Device Identifier: 00380652409698
• UDI-Public: (01)00380652409698(17)281130(11)241202(10)15957670
• 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
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/12/2025

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: CNW0T3
• Device Lot Number: 15957670
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2024
• 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 MONARCH IV IOL DELIVERY SYSTEM INJECTOR; DUOVISC VISCOELASTIC SYSTEM; MONARCH II LOADING FORCEPS; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; ORA SYSTEM WITH VERIFEYE MESSAGING
• Patient Age: 71 YR
• Patient Sex: Female