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	02/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A non-healthcare professional reported that during surgery, lens was implanted and explanted.Additional information has been requested and received stating that, according to surgeon the 3 dots for toric was not aligned with haptic.In the surgeon opinion, company defective lens caused or contributed to the event.There was no patient harm.Surgeon implanted another unspecified lens.
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The lens was returned in the lens case.Viscoelastic was observed on the lens.The lens had been cut into two pieces, typical of a removal.The lens portions were cleaned with klrp (klotho-related protein klrp).The toric axis marks were misaligned.The provided photo matched the returned product.Product history records were reviewed, and documentation indicated the product met release criteria.Qualified associated products were indicated.The lens was returned was observed to have misaligned toric axis marks.The root cause for the observed misalignment was manufacturing related.The root cause of this event was due to the milling operator not following the procedure.The milling operator did not align the mill correctly, causing the toric axis marks to be misaligned for this lens.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.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: 21721549
• Report Number: 1119421-2025-00870
• Device Sequence Number: 9492125
• Product Code: MJP
• UDI-Device Identifier: 00380652409681
• UDI-Public: (01)00380652409681(17)281103(11)241105(10)15952953
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (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): 05/16/2025

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: 15952953
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/03/2025
• Supplement Date Received by Manufacturer: 04/24/2025
• Initial Report FDA Received Date: 03/28/2025
• Supplement Report FDA Received Date: 05/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2024
• 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: HEALON OVD; MC PHEARSON FORCEPS; MONARCH II LOADING FORCEPS; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, INJECTOR
• Patient Age: 72 YR
• Patient Sex: Female