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

Model Number	CNW0T4
Medical Device Problem Codes	Product Quality Problem (1506); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/27/2025
Type of Reportable Event	Serious Injury
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 health care professional reported with a description of the wrong intraocular lens was implanted.The lens was explanted in secondary procedure and replaced with company lens.Additional information has been requested.
Additional Manufacturer Narrative
Corrected information provided in h.6., and h.11.Correction: on initial mdr the product code of a0201 was an error.It should have been a24 on the original mdr.Additional information was provided in h.3., h.6.And h.11.The product was not returned for analysis.Follow up states sales rep.Informed that the mistake was not in customer service.Sales rep added that while she was on vacation, the customer contacted her coverage and there was a mix up.Hcp should have checked it.The root cause for the reported complaint appears to be a coincidental event that was related to implantation of an incorrect lens as the file states sales rep.Informed that the mistake was not in customer service.Based on this information, the device did not cause/contribute 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 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: 21950859
• Report Number: 9612169-2025-00966
• Device Sequence Number: 21012626
• Product Code: MJP
• UDI-Device Identifier: 00380652410106
• UDI-Public: (01)00380652410106(17)270809(11)230811(10)25692997
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: CNW0T4
• Device Lot Number: 25692997
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/04/2025
• Supplement Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 05/02/2025
• Supplement Report FDA Received Date: 07/16/2025
• Date Device Manufactured: 08/11/2023
• 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: CLAREON VIVITY TORIC IOL
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female