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	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Impairment (2138)
Date of Event	04/07/2025
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 physician reported that following the intraocular lens (iol) implant procedure, the patient had blurry vision.The lens was explanted and exchanged with unspecified lens following the initial procedure.Clinical reason for explant was mentioned as rotation of iol and residual astigmatism.Additional information has been requested.

• 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: 22053981
• Report Number: 9612169-2025-01084
• Device Sequence Number: 5192860
• Product Code: MJP
• UDI-Device Identifier: 00380652455534
• UDI-Public: (01)00380652455534(17)270118(11)230120(10)25569145
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/20/2025

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 Model Number: CCWET4
• Device Lot Number: 25569145
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2025
• Initial Report FDA Received Date: 05/20/2025
• Date Device Manufactured: 01/20/2023
• 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