MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON CLAREON VIVITY TORIC EXTENDED VISION HYDROPHOBIC IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	CNWET3
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Impairment (2138)
Date of Event	12/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A non-healthcare professional reported that, after intraocular lens implantation surgery, the patient experienced blurred vision.Hence the lens was explanted and replaced with another lens in a secondary procedure.The clinical reason for explant was rotation of the lens, myopic shift.Additional information was received stating that, on post-operative week 1visit, it was noted that the patient vision was 20/70 uncorrected and the lens rotated from 93 degrees (initial implantation axis) to 44 degrees.The patient also had a myopic result approximately -0.75 from where the target was.In the surgeon opinion the rotation was due to the fact that the patient was a high myope (-9.50 pre-operative) and was diagnosed to have loose zonules after surgery.There was no patient harm.
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).

• Brand Name: CLAREON VIVITY TORIC EXTENDED VISION HYDROPHOBIC IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 21181045
• Report Number: 1119421-2025-00193
• Device Sequence Number: 8527858
• Product Code: MJP
• UDI-Device Identifier: 00380652466288
• UDI-Public: (01)00380652466288(17)270307(11)230309(10)15576472
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Report Date (Section B): 01/17/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: CNWET3
• Device Catalogue Number: CNWET3.125
• Device Lot Number: 15576472
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/27/2024
• Initial Report FDA Received Date: 01/17/2025
• Date Device Manufactured: 03/09/2023
• 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