MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON VIVITY TORIC EXTENDED VISION HYDROPHOBIC IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	CNWET4
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A surgeon reported that during an intraocular lens (iol) implant procedure, implantation of the iol was not possible due to detachment of the haptic element from the optic part during placement of the iol into the cartridge.There was no patient contact.The surgery was completed on the same day with subsequent secondary iol implantation.Additional information has been 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).
Additional Manufacturer Narrative
Additional information was provided in h.3., h.6.And h.11.The product was not returned for analysis.Only photos were returned.The reported complaint was observed on the returned photos.Photos provided show an intraocular lens (iol) on a lens case base.One haptic appears to be broken/torn.Photo review - company cartridge: two photos were provided that showed the same view of the company iii cartridge.The view was from the bottom.The cartridge was beside the opened lens case.There appeared to be viscoelastic in the cartridge.There did not appear to be any viscoelastic in the nozzle or tip, which would indicate the issue occurred during initial lens loading/advancement.No cartridge damage was visible in the provided view.Placement in a handpiece could not be determined as the view was from the bottom.A company iii handpiece, forceps, and other metal instruments were pictured along with a vial of ovd.Based on our observation of the attached photo, one haptic appears to be broken/torn.A definitive determination of the reported complaint cannot be made without the evaluation of the physical product.The product was subject to handling.The detachment of the haptic element from the optic was observed during placement of the iol into the cartridge.A final root cause cannot be determined based on available information.Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON VIVITY TORIC EXTENDED VISION HYDROPHOBIC IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer (Section G): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 24049989
• Report Number: 9612169-2026-00117
• Device Sequence Number: 9745562
• Product Code: MJP
• UDI-Device Identifier: 00380652466691
• UDI-Public: (01)00380652466691(17)280703(11)240705(10)25883576
• Combination Product (Y/N): N
• Initial Reporter Country: BO
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2026

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: CNWET4
• Device Lot Number: 25883576
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/19/2025
• Supplement Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 04/10/2026
• Date Device Manufactured: 07/05/2024
• 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: MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D.; MONARCH III IOL DELIVERY SYSTEM, INJECTOR.; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE.
• Patient Sex: Unknown