MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON PANOPTIX TORIC TRIFOCAL HYDROPHOBIC IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	CNWTT3
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A nurse reported that during an intraocular lens (iol) implantation procedure, the lens was scratched by the injector.Additional information received indicates that the scratch was identified by the surgeon under the microscope during lens insertion.The lens was not implanted but removed before full insertion.No harm was caused to the patient.
Additional Manufacturer Narrative
A sample device 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 d.9., h.3., h.6.And h.11.The product was returned for analysis, and damage was observed to the iol (intraocular lens).No cartridge was returned.Iol returned pressed down into well area of iol case base.Solution is dried on the iol.One haptic is broken/torn and is returned, the other haptic is slightly deformed.The lens was cleaned for further evaluation.The optic is scratched/marked-rejectable; there is also a big fracture in the optic.We are unable to determine the root cause for the reported complaint "lenses that were scratched by the injector ".One haptic is broken/torn and is returned, the other haptic is slightly deformed.The optic is scratched/marked-rejectable; there is also a big fracture in the optic.The reported damage occurred at the time of iol went out of the cartridge.No cartridge was returned; due to this, we are unable to complete a thorough investigation to determine a root cause.In addition to this, all iols are 100% cosmetically inspected as per approved manufacturing procedures and the observed lens condition would not meet our current release criteria.Based on these investigation findings, we are unable to verify if the iol contributed to the event.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 PANOPTIX TORIC TRIFOCAL 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: 23299515
• Report Number: 9612169-2025-02050
• Device Sequence Number: 4863700
• Product Code: MJP
• UDI-Device Identifier: 00380652468558
• UDI-Public: (01)00380652468558(17)270122(11)230124(10)25579968
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2026

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: CNWTT3
• Device Catalogue Number: CNWTT3.210
• Device Lot Number: 25579968
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/26/2025
• Supplement Date Received by Manufacturer: 05/08/2026
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2023
• 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: PROVISC OVD.
• Patient Sex: Unknown