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

Model Number	CCWET3
Medical Device Problem Codes	Material Discolored (1170); Material Deformation (2976)
Health Effect - Clinical Codes	Blurred Vision (2137); Insufficient Information (4580)
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, had glistening on lens.Additional information has been requested.
Additional Manufacturer Narrative
Additional information was provided in a.1., b.2., b.5., d.6.A., h.3.And h.6.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been requested and received stating the patient experienced blurred vision.The iol was exchanged for non company lens 01 months 12 days following the initial implant procedure.Clinical reason for explant was multiple glistening or deposits in the iol.
Additional Manufacturer Narrative
Additional information was provided in h.3., h.6.And h.11.The product was returned for analysis and the reported complaint was not observed.Lens received in two segments adhered to backing paper of an unknown open peel pouch, in a sample container.Solution is dried on the intraocular lens (iol).No glistening observed on dry iol.The iol was cleaned for further evaluation.No glistening observed on cleaned and wet iol.The haptics are intact.The optic is scratched/marked-rejectable.No root cause identified as the reported complaint "blurred vision, multiple glistening or deposits in the iol" was not observed.All iols are 100% cosmetically inspected as per approved manufacturing procedures.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: 22046251
• Report Number: 9612169-2025-01076
• Device Sequence Number: 15673502
• Product Code: MJP
• UDI-Device Identifier: 00380652486002
• UDI-Public: (01)00380652486002(17)251115(11)211117(10)25307498
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/07/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/15/2025
• Device Model Number: CCWET3
• Device Catalogue Number: CCWET3.100
• Device Lot Number: 25307498
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/29/2025
• Supplement Date Received by Manufacturer: 05/20/2025; 07/15/2025
• Initial Report FDA Received Date: 05/19/2025
• Supplement Report FDA Received Date: 06/11/2025; 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown