Test lens did not meet near visual efficacy endpoints

The objective of this 12-month clinical investigation is to evaluate the safety and effectiveness of the Bausch & Lomb Akreos MI Five-O intraocular lens (IOL). Effectiveness will be shown through the demonstration of accurate distance correction and safety will be demonstrated through the monitoring of adverse events.

Inclusion Criteria:

• Subjects must have a clinically documented diagnosis of age-related cataract.
• Subjects must have clear intraocular media other than cataract.
• Subjects must be undergoing primary in-the-bag intraocular lens implantation for the correction of aphakia following continuous curvilinear anterior capsulotomy and phacoemulsification cataract extraction.

Exclusion Criteria:

• Subjects with any anterior segment pathology for which extracapsular phacoemulsification cataract surgery would be contraindicated.
• Subjects with diagnosis of degenerative visual disorder.
• Subjects who have any inflammation or edema (swelling) of the cornea.
• Subjects with immunodeficiency disorders.
• Subjects who have had previous intraocular surgery in the study eye.
• Subjects with incomplete/damaged zonule, or with conditions associated with increased risk of zonular rupture.
• Subjects with chronic use of systemic steroids or immunosuppressive medications.