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

Model Number	CNW0T3
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2025
Type of Reportable Event	Malfunction
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).
Event or Problem Description
A non-healthcare professional reported that during surgery, they noticed that the haptic defect was detected.Additional information has been requested and received stating that the defect of the haptic part of the lens detected during surgery.There was no patient contact.Surgery was completed and lens was replaced.Patient condition noted to be satisfactory.
Additional Manufacturer Narrative
Corrected information has been provided in d.10.Additional information has been provided in h.3., h.6., and h.11.The product was not returned for analysis.Only photo was returned.The reported complaint cannot be confirmed from the returned photo.A photo was provided.The photo showed the disassembled lens care lid and base.A company cartridge was also pictured on top of the lens case.The view was from the bottom.A yellow lens was visible advanced just past the loading area.Unable to determine if viscoelastic was in the cartridge.The haptic positions could not be determined due to the quality of the photo.The complainant indicates the use of non-company as a viscoelastic which is not qualified for use with the associated iol model.The reported complaint cannot be confirmed from the provided photo, however, based on the information provided by the customer, the most likely root cause is failure to follow ifu, as the surgeon states the use of non-qualified viscoelastic.The use of an unqualified combination may cause damage to the iol and potential complications during the implantation process.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 TORIC 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: 23596019
• Report Number: 9612169-2025-02313
• Device Sequence Number: 21166313
• Product Code: MJP
• UDI-Device Identifier: 00380652402309
• UDI-Public: (01)00380652402309(17)290511(11)250513(10)26023464
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2026

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: CNW0T3
• Device Lot Number: 26023464
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/22/2025
• Supplement Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 11/19/2025
• Supplement Report FDA Received Date: 02/06/2026
• Date Device Manufactured: 05/13/2025
• 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: HILURON 1.4%.; MONARCH II IOL, INJECTOR.; MONARCH III IOL, CARTRIDGE D.; MONARCH IOL, INJECTOR, UNSPECIFIED.
• Patient Age: 71 YR
• Patient Sex: Female