Clinical Investigation of Expanded Designs of a Multifocal IOL

Inclusion Criteria:

- Minimum 18 years of age

- Bilateral cataracts for which phacoemulsification extraction and posterior IOL
implantation have been planned for both eyes

- Preoperative best-corrected distance visual acuity (BCDVA) of 20/40 or worse
(Snellen) with or without a glare source

- Potential for postoperative best-corrected visual acuity of 20/25 or better

- Preoperative corneal astigmatism of 1.0 D or less with normal corneal topography and
no irregular corneal astigmatism

- Clear intraocular media, other than cataract

- Availability, willingness and sufficient cognitive awareness to comply with
examination procedures

- Signed informed consent and HIPAA authorization or equivalent documentation necessary
to comply with applicable privacy laws pertaining to medical treatment in the
governing countries

- Ability to understand and respond to a questionnaire verbally administered in English

Exclusion Criteria:

- Requiring an intraocular lens power outside the available range of +16.0 to +28.0 D

- Pupil abnormalities (non-reactive, fixed pupils, or abnormally shaped pupils)

- Recent ocular trauma or ocular surgery that is not resolved/stable or may affect
visual outcomes

- Prior refractive (LASIK, LASEK, RK, PRK, etc.) or intraocular surgery

- Corneal abnormalities such as stromal, epithelial or endothelial dystrophies that are
predicted to cause visual acuity losses to a level of 20/30 or worse during the study

- Inability to achieve keratometric stability for contact lens wearers

- Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration or
other retinal disorders) that are predicted to cause visual acuity losses to a level
of 20/30 or worse during the study

- Subjects with conditions associated with increased risk of zonular rupture, including
capsular or zonular abnormalities that may lead to IOL decentration, including
pseudoexfoliation, trauma, or posterior capsule defects

- Use of systemic or ocular medications that may affect vision

- Prior, current, or anticipated use during the course of the 12-month study of
tamsulosin or silodosin (e.g., Flomax®, Flomaxtra®, Rapaflo®) likely, in the opinion
of the investigator, to cause poor dilation or lack of adequate iris structure to
perform standard cataract surgery

- Inability to focus, fixate or maintain binocular vision for prolonged periods of time
(e.g., due to strabismus, nystagmus, etc.)

- Poorly-controlled diabetes

- Acute, chronic, or uncontrolled systemic or ocular disease or illness that, in the
opinion of the investigator, would increase the operative risk or confound the
outcomes of the study (e.g., immunocompromised, connective tissue disease, suspected
glaucoma, glaucomatous changes in the fundus or visual field, ocular inflammation,
etc.). Note: ocular hypertension without glaucomatous changes is acceptable.

- Known ocular disease or pathology that may affect visual acuity or that may be
expected to require retinal laser treatment or other surgical intervention during the
course of the study (macular degeneration, cystoid macular edema, diabetic
retinopathy, etc.)

- Patient is pregnant, plans to become pregnant, is lactating or has another condition
associated with the fluctuation of hormones that could lead to refractive changes

- Concurrent participation or participation within 30 days prior to preoperative visit
in any other clinical trial

- Desire for monovision correction