Safety and Effectiveness of the Calhoun Vision Light Adjustable Intraocular Lens (LAL)

Inclusion Criteria:

- Pre-operative regular corneal astigmatism less than or equal to 1.00 diopters by
keratometry.

- Adults between the ages of 40 and 80 inclusive.

- Cataract causing reduction in best spectacle-corrected visual acuity to a level of
20/32 or worse.

- Best corrected visual acuity projected (by clinical estimate based upon past ocular
history and retinal exam) to be 20/25 or better after cataract removal and IOL
implantation.

- Clear intraocular media other than cataract.

- Potentially good vision in the fellow eye with BCVA 20/40 or better.

- Willing and able to comply with the schedule for power adjustment/lock-in treatments
and the schedule for follow-up visits.

- Fully dilated pupil diameter of more than or equal to 7.0 mm.

Exclusion Criteria:

- Zonular laxity or dehiscence.

- Pseudoexfoliation.

- Age related macular degeneration involving the presence of geographic atrophy or soft
drusen.

- Retinal degenerative disorder that is expected to cause future vision loss.

- Diabetes with any evidence of retinopathy.

- Evidence of glaucomatous optic neuropathy.

- History of uveitis.

- Significant anterior segment pathology, such as rubeosis iridis, aniridia, or iris
coloboma.

- Corneal pathology that is either progressive or sufficient to reduce BCVA to 20/25 or
worse.

- Keratoconus or suspected of having keratoconus.

- Corneal dystrophy including basement membrane dystrophy.

- Previous corneal or intraocular surgery

- Systemic medication that may increase sensitivity to UV light such as tetracycline,
doxycycline, psoralens, amiodarone, and phenothiazines.

- Complications during cataract surgery including posterior capsule rupture, zonular
rupture, radial capsulorhexis tear, vitreous loss, iris trauma, corneal complications
or any intraoperative abnormality that may affect the postoperative pupillary
dilation, or the centration or tilt of the intraocular lens.