Artisan Aphakia Lens for the Correction of Aphakia in Children

Inclusion Criteria:

- 2 to 21 years of age

- Have a visually significant cataract or need IOL replacement surgery

- Compromised capsular bag prohibiting implantation of standard posterior IOL

- Subject or parent/guardian must be able to comply with visit schedule and study
requirements

- Subject's legal representative must be able to sign the Informed Consent

Exclusion Criteria:

- Under 2 years of age

- Unable to meet Postoperative evaluation requirements

- No useful vision or vision potential in fellow eye

- Mentally retarded patients

- History of corneal disease

- Abnormality of the iris or ocular structure

- ACD less than 3.2 mm

- Uncontrolled glaucoma

- IOP > 25 mmHg

- Chronic or recurrent uveitis

- Preexisting macular pathology that may complicate the ability to assess the benefit
of this lens

- Retinal detachment or family history

- Retinal disease that may limit visual potential

- Optic nerve disease that may limit visual potential

- Diabetes mellitus

- Pregnant, lactating or plan to become pregnant