Evaluation of the Safety & Effectiveness of the Bausch & Lomb AKREOS® TL Intraocular Lens

A Prospective, Multi-Center Clinical Investigation to Evaluate the Safety & Effectiveness of the Bausch & Lomb AKREOS® TL (Model MI60) Intraocular Lens

This study is to evaluate the safety and effectiveness of the Bausch & Lomb Akreos TL (thin lens) intraocular lens (IOL) following implantation in adults requiring cataract surgery.

Inclusion Criteria:

• Subjects must have a clinically documented diagnosis of age-related cataract that is considered amenable to treatment with standard phacoemulsification/extracapsular cataract extraction.
• Subjects must be undergoing primary intraocular lens implantation for the correction of aphakia following continuous curvilinear anterior capsulotomy and phacoemulsification cataract extraction.
• Subjects must require a lens power from 15 to 30 diopters.
• Subjects must have a visual potential of 20/40 or better in the study eye.

Exclusion Criteria:

• Subjects with any anterior segment pathology for which extracapsular phacoemulsification cataract surgery would be contraindicated.
• Subjects with any inflammation or edema (swelling) of the cornea.
• Subjects with uncontrolled glaucoma or glaucoma under current treatment in the study eye or with ocular hypertension.
• Subjects with previous retinal detachment.
• Subjects with diabetic retinopathy (proliferative or non-proliferative).
• Subjects with rubella, bilateral congenital, traumatic, or complicated cataract.
• Subjects who have had previous ocular surgery in the planned operative eye, excluding ocular adnexa surgery.
• Subjects who have already received an Akreos TL IOL in the fellow eye.