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

Model Number	CNW0T5
Medical Device Problem Code	Failure to Eject (4010)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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 reporter states that the "surgeon used the wrong cartridge so it did not get implanted properly".The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non-healthcare professional reported that surgeon used wrong cartridge and the lens did not get implanted properly.Additional information was requested, but no further information is available.
Additional Manufacturer Narrative
Additional information provided in b.2., b.5., h.3., h.6.And h.10.The root cause for the reported complaint appears to be a coincidental event unrelated to product as user facility reported that the event was related to wrong cartridge being used by surgeon during the procedure.All product and batch history records are quality reviewed prior to product release.Based on information received following submission of the initial report, this event does not meet criteria for reporting as a reportable malfunction.No further reports required the manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information received confirmed that there was no patient contact.

• 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: 16859926
• Report Number: 9612169-2023-00335
• Device Sequence Number: 14908625
• Product Code: MJP
• UDI-Device Identifier: 00380652410755
• UDI-Public: 00380652410755
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2023

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: 02/26/2025
• Device Model Number: CNW0T5
• Device Lot Number: 25271539
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/10/2023
• Supplement Date Received by Manufacturer: 06/01/2023
• Initial Report FDA Received Date: 05/03/2023
• Supplement Report FDA Received Date: 06/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2021
• 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
• Patient Sex: Unknown