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

Model Number	CNW0T7
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/22/2024
Type of Reportable Event	Malfunction
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 received that only crack was found on lens optic there was no foreign material.
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 provided in d.9., h.3., h.6., and h.11.The product was returned for analysis and damage was observed to the iol.Iol returned positioned correctly in the lens case.Solution is dried on both surfaces of the optic and haptics.One of the haptic tips is broken/torn and is returned taped to lens case base.The other haptic is intact.The optic is cracked/fractured and scratched/marked-rejectable we are unable to determine the root cause for the reported complaint crack was found on lens optic.The product was subject to handling and the reported damage was highlighted post implantation.The reported complaint is lacking in relevant information such as associated products (cartridge, handpiece, viscoelastic) used to complete a thorough investigation.Due to the lack of information, we are unable to verify if the product contributed to the event.In addition to this, all iols are 100% 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).

• 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: 21126783
• Report Number: 9612169-2025-00080
• Device Sequence Number: 6957722
• 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): 03/19/2025

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: 02/19/2025
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 03/19/2025
• 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