MAUDE Adverse Event Report: Alcon Research, LLC - Huntington Clareon Toric IOL; Lens, Intraocular, Toric Optics

Model Number	CNW0T4
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A non-healthcare professional reported that, following cataract surgery with an intraocular lens implant procedure, the iol rotated after implantation.Hence, the lens was explanted and replaced with a company lens of a different model and diopter during a secondary procedure.The clinical reason for explantation was mechanical breakdown of the iol.There was no patient harm, and the surgeon¿s prognosis was good.Additional information has been requested but is not available at the time of this report.
Additional Manufacturer Narrative
The lens was returned wrapped in surgical gauze, inside an envelope.Solution was dried on the lens.One haptic was broken (possibly cut).The optic was cut into pieces, typical of insertion and removal.The lens dimensions could not be reverified due to the lens being returned in pieces.A batch 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 medical device file were met.Qualified associated products were indicated however, they would be unrelated to the reported event.The product investigation could not determine a root cause for the reported iol (intraocular lens) rotated off axis.No reason was provided for the rotation.The lens dimensions could not be reverified due to the lens being returned in pieces.Information was provided that the lens was exchanged due to rotation; however, the original company lens was replaced with another lens from the same company with a different model and diopter power.The exchange for the same model with a difference in cylinder and spherical power may suggest that the replacement lens model was an improved choice for the patient's vision needs.The investigation has been completed based on current information.Receipt of additional relevant information or supporting materials will prompt a re-evaluation of the complaint investigation.No adverse trends have been observed associated with the reported product and event.No further action has been identified for this reported event.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.No further action is warranted at this time.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 ; +1(800)757-9780
• MDR Report Key: 50774472
• Report Number: 1119421-2026-01876
• Device Sequence Number: 9424553
• Product Code: MJP
• UDI-Device Identifier: 00380652410144
• UDI-Public: (01)00380652410144(17)270827(11)230829(10)15702836
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/15/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CNW0T4
• Device Lot Number: 15702836
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/01/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/19/2026
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2023
• 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: Clareon Toric IOL.; MONARCH III IOL Delivery System, Cartridge D.; MONARCH III IOL Delivery System, Injector.; PROVISC Ophthalmic ViscoSurgical Device.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male