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

Model Number	CCWET6
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Impairment (2138); Visual Disturbances (2140)
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 non-healthcare professional reported that following an intraocular lens (iol) implant procedure, the patient experienced positive dysphotopsia, light sensitivity, trouble driving and visual discomfort.The lens was planned to be explanted.Additional information was received, the lens was explanted and replaced with another lens model.In the surgeon¿s opinion missed optical target prior lasik (laser-assisted in situ keratomileusis) caused the event and there was no patient harm.
Additional Manufacturer Narrative
Additional information was provided in h.3.,h.6 and h.11.As per the surgeon opinion the iol (intra ocular lens) did not contribute to the event and was due to missed optical target, prior lasik (laser-assisted in situ keratomileusis).The root cause for the reported complaint appears to be a coincidental event that was unrelated to the product as user facility reported that according to the surgeon, the iol did not cause the event.Based on this information, the product did not cause or contribute to the event.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: 20569416
• Report Number: 9612169-2024-01104
• Device Sequence Number: 12627605
• Product Code: MJP
• UDI-Device Identifier: 00380652456357
• UDI-Public: (01)00380652456357(17)250402(11)211109(10)25298373
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/02/2025
• Device Model Number: CCWET6
• Device Catalogue Number: CCWET6.195
• Device Lot Number: 25298373
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/02/2024
• Supplement Date Received by Manufacturer: 12/11/2024
• Initial Report FDA Received Date: 10/30/2024
• Supplement Report FDA Received Date: 01/03/2025
• Date Device Manufactured: 11/09/2021
• 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: ORA SYSTEM WITH VERIFEYE MESSAGING.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female