MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON VIVITY TORIC EXTENDED VISION UV ABSORBING IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	CCWET4
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A non health care professional reported that during surgery, they have explanted the lens due to it was scratched.Additional information has been received it states that when loading lens was scratched.Lens was implanted then explanted after doctor saw the scratch and replaced with another lens.Procedure completed the same day.There was no impact to the patient.
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
The product was not returned for analysis.Additional information stated in the file that the lens was loaded incorrectly and in the surgeon opinion this was the cause of the event.The root cause for the reported complaint appears to be a coincidental event that was unrelated to the product as it is stated in the file that the lens was loaded incorrectly and in the surgeon opinion this was the cause of the event.Based on this information, the product 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 VIVITY TORIC EXTENDED VISION UV ABSORBING 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: 20621512
• Report Number: 9612169-2024-01125
• Device Sequence Number: 8792720
• Product Code: MJP
• UDI-Device Identifier: 00380652455718
• UDI-Public: (01)00380652455718(17)260116(11)220118(10)25341459
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2025

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 Expiration Date: 01/16/2026
• Device Model Number: CCWET4
• Device Catalogue Number: CCWET4.235
• Device Lot Number: 25341459
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/10/2024
• Supplement Date Received by Manufacturer: 12/12/2024
• Initial Report FDA Received Date: 11/06/2024
• Supplement Report FDA Received Date: 01/03/2025
• Date Device Manufactured: 01/18/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN CARTRIDGE, HANDPIECE, OVD
• Patient Age: 75 YR
• Patient Sex: Female