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

Model Number	CNW0T4
Medical Device Problem Code	Unintended Ejection (1234)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/10/2023
Type of Reportable Event	Malfunction
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).
Event or Problem Description
A facility representative reported that with a description of defective intraocular lens (iol).The reporter stated that the lens were discharged abnormally from the cartridge.Additional information has been requested.
Additional Manufacturer Narrative
The product was returned for analysis and damage was observed to the iol.No cartridge was returned.Iol returned pressed down into well area of iol case base.Solution and what appears to be blood is dried on the iol.Both haptics are adhered to the optic surface with solution.The optic is bent and has light scratches.No cartridge returned.The product investigation could not identify the root cause for the reported complaint "lens abnormal discharge from the cartridge".No cartridge was returned.We are unable to complete a thorough investigation to determine a root cause.Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been received and stated that the lens were discharged abnormally from the cartridge and surgery was completed with another lens and there was no patient contact.
Additional Manufacturer Narrative
Based on information received following submission of the initial report, this event does not meet criteria for reporting as a malfunction.No further reports required.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: 18090308
• Report Number: 9612169-2023-00775
• Device Sequence Number: 6669804
• Product Code: MJP
• UDI-Device Identifier: 00380652410304
• UDI-Public: 00380652410304
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/13/2024

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 Expiration Date: 02/25/2025
• Device Model Number: CNW0T4
• Device Lot Number: 25267794
• 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: 10/12/2023
• Supplement Date Received by Manufacturer: 12/20/2023; 02/14/2024
• Initial Report FDA Received Date: 11/08/2023
• Supplement Report FDA Received Date: 01/12/2024; 03/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2021
• 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: MONARCH IOL DELIVERY SYSTEM, CARTRIDGE.
• Patient Sex: Unknown