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

Model Number	CNW0T7
Medical Device Problem Codes	Crack (1135); Particulates (1451)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information provided in d.9., h.3., h.6.And h.11.Iol returned in lens case.Solution is dried on both surfaces of the optic and haptics.Both haptics are bent/deformed, one haptic has a mark near the tip.The optic edge is damaged and there is a crack or fracture near the center of the optic.There is foreign material on the optic surface.No cartridge returned.Provided photo appears to show an implanted iol.There appears to be a line or crack in the center of the optic.There also appears to be material around the crack, this material could potentially be optic surface damage.The clear material was isolated and analysed using microscopic fourier transform infrared spectroscopy (micro ft-ir).Comparison of the clear materials generated ir spectra to a library of spectra finds the best match to be polypropylene (ft-ir spectra 1).We are unable to determine the root cause for the reported complaint "crack and foreign material were found on lens optic".The product was subject to handling and the reported damage was highlighted after "insertion".The reported complaint is lacking in relevant information such as associated products (cartridge, handpiece, viscoelastic) used to complete a thorough investigation.The foreign material was sent to ftw lab for further evaluation.Based on the spectral comparison results, the best match was found to be polypropylene.Polypropylene is a commonly used material, including in many medical products/environments.The origin of the material could not be determined.In addition to this, all iols are 100 percent cosmetically inspected as per approved manufacturing procedures and the observed lens damage would not meet our current release criteria.Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).
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 physician reported that during the lens implantation into the eye, noticed crack and a foreign material on optic of lens.The surgery was completed after replacing the product with another lens.Additional information has been requested.

• 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: 21126786
• Report Number: 9612169-2025-00081
• Device Sequence Number: 6982867
• Product Code: MJP
• UDI-Device Identifier: 00380652411790
• UDI-Public: (01)00380652411790(17)261120(11)221122(10)25537393
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 04/11/2025

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: CNW0T7
• Device Lot Number: 25537393
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/18/2024
• Supplement Date Received by Manufacturer: 03/13/2025
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 04/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2022
• 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
• Patient Sex: Unknown