A Real-World Evidence (RWE) Long-Term Follow-Up Study to Assess Outcomes of Alcon Monofocal Intraocular Lenses

A Real-World Evidence (RWE) Long-Term Follow-Up Study to Assess Outcomes of Alcon Monofocal Intraocular Lenses

The purpose of this post-market clinical follow-up (PMCF) study is to describe the long-term safety and performance of AcrySof Single-Piece and AcrySof Multi-Piece monofocal intraocular lenses (IOLs).

The study includes a retrospective chart review for pre-operative, operative, and post-operative data collection, and a prospective, standard-of-care visit to collect study endpoints.

Key Inclusion Criteria:

• Subject is implanted with one of the study IOL models between 3 and 5 years previously.
• Subject follow-up is expected to be possible during the duration of the study.
• Subject or legally authorized representative must be able to understand and sign the IRB/EC approved Informed Consent form. Minor subjects will complete an Assent Form.
• Documented medical history and required pre-operative baseline information is available for retrospective data collection.

Key Exclusion Criteria:

• Subject is participating in a separate investigational drug or device study.
• Pregnancy at the time of enrollment.