Post Market Clinical Follow-up (PMCF) Study of Clareon Vivity & Clareon PanOptix

Long-term Evaluation of Safety and Performance of Clareon Presbyopia-Correcting Intraocular Lenses (IOLs)

The purpose of this Post-Market Clinical Follow-up study is to describe the long-term safety and performance of the Clareon Vivity and Vivity Toric and Clareon PanOptix and PanOptix Toric IOLs.

Subjects will be recruited from a population that has already undergone lens implantation. Retrospective data will be collected from the pre-operative and surgical visits and any safety outcomes reported prior to enrollment. Prospective data will be collected from time of study enrollment through the Year 3 follow-up visit.

Key Inclusion Criteria:

• Subject or legally authorized representative must be able to understand and sign an approved Informed Consent Form.
• Subject must have had bilateral implantation of Clareon Vivity, Clareon Vivity Toric, Clareon PanOptix, or Clareon PanOptix Toric IOLs between 3-6 months prior to enrollment.
• Subject must have a documented medical history and required pre-operative baseline information available for retrospective data collection.
• Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

• Subject is currently participating in another investigational drug or device study.
• Subject has had corneal refractive surgery after Clareon Vivity, Clareon Vivity Toric, Clareon PanOptix, or Clareon PanOptix Toric IOL implantation.
• Subject is pregnant at the time of enrollment.
• Other protocol-defined exclusion criteria may apply.