Evaluate the Safety and Effectiveness of the enVista® One-Piece Hydrophobic Acrylic Trifocal Intraocular Lens

Cataracts are a common condition in adults over 40 years of age, and surgical replacement of
the cataractous lens with an intraocular lens (IOL) remains an effective way to restore
vision to cataract patients.The objective of the study is to evaluate the safety and
effectiveness of the enVista trifocal intraocular lens when implanted in the capsular bag.

Inclusion Criteria:

1. Subjects must be 22 years of age or older on the date the Informed Consent Form (ICF)
is signed.

2. Subjects must have the capability to understand and provide written informed consent
on the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved
Informed Consent Form (ICF) and authorization as appropriate for local privacy
regulations.

3. Subjects must have a BCDVA equal to or worse than 20/40 in each eye, with or without a
glare source, due to a clinically significant cataract (cortical, nuclear,
subcapsular, or combination) that is considered amenable to treatment with standard
phacoemulsification cataract extraction and capsular IOL implantation.

4. Subjects must have a BCDVA projected to be better than 20/32 after IOL implantation in
each eye, as determined by the medical judgment of the Investigator or measured by
potential acuity meter (PAM) testing, if necessary.

5. Subjects must have clear intraocular media other than the cataract in both eyes.

Exclusion Criteria:

1. Subjects who have participated in any drug or device clinical investigation within 30
days prior to entry into this study and/or will participate in another investigation
during the period of study participation.

2. Subjects who have any corneal pathology (e.g., significant scarring, guttata,
inflammation, edema, dystrophy, etc.) in either eye.

3. Subjects who have significant anterior segment pathology that might increase
intraoperative risk or compromise IOL stability (e.g., pseudoexfoliation syndrome,
synechiae, iris atrophy, traumatic cataract, lens subluxation, traumatic zonulolysis,
zonular dialysis, evident zonular weakness or dehiscence, hypermature or brunescent
cataract, etc.) in either eye.

4. Subjects who have uncontrolled glaucoma in either eye.