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

Model Number	CNW0T6
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A nurse reported that during an intraocular lens (iol) implant procedure, with these two iol¿s, they were loaded by two different techs, with a different cartridge, and a different injector each time (in the same patient).They were performed on the same patient, using the same ( toric & sphere) iol power & model with, i believe, the same reference numbers.As they didn¿t have a third iol of that power, they obtained a preloaded toric iol of the same power but the colorless version.On the initial attempt to place in the patient, it was inadvertently injected outside of the patient¿s eye.Therefore, it had to be manually loaded and then injected which proceeded uneventfully.The first iol had the tip of the of the leading haptic truncated off, the trailing haptic broke such that two separate pieces of the haptic broke off, and the edge of the iol optic and surface of the iol had some damage.The second iol injected, and the optic was cut nearly completely in halves down the middle of the optic.Additional information was requested.
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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
Additional Manufacturer Narrative
Correction information was provided in a.2., a.3.A., b.3., and d.10.The manufacturer internal reference number is: (b)(4).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.

• 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: 24043638
• Report Number: 1119421-2026-00100
• Device Sequence Number: 9010613
• Product Code: MJP
• UDI-Device Identifier: 00380652411264
• UDI-Public: (01)00380652411264(17)270116(11)230118(10)15570808
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2026

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: CNW0T6
• Device Lot Number: 15570808
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/22/2025
• Supplement Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 03/19/2026
• Date Device Manufactured: 01/18/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DUOVISC; FECHTNER PICKUP FORCEPS; MONARCH III CARTRIDGE C; MONARCH III IOL, INJECTOR
• Patient Age: 77 YR
• Patient Sex: Male