Study to Evaluate the Safety and Effectiveness of the enVista® Beyond (EY) EDF Intraocular Lens in Subjects Undergoing Cataract Extraction

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 consenton the Institutional Review Board (IRB)/Research Ethics Board (REB) approved ICF andauthorization as appropriate for local privacy regulations.

3. Subjects must have a BCDVA equal to or worse than 20/40 in each eye, with or withouta glare source present (Brightness Acuity Tester), or have significantcataract-related visual symptoms, due to a clinically significant cataract (cortical, nuclear, subcapsular, or combination) that is considered amenable totreatment with standard phacoemulsification cataract extraction and capsular IOLimplantation.

4. Subjects must have preoperative corneal astigmatism less than 1.0 D for each eye.

5. Subjects must have a BCDVA projected to be better than 20/30 after cataract removaland IOL implantation in each eye, as determined by the medical judgment of theInvestigator or measured by potential acuity meter (PAM) testing, if necessary.

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

7. Contact lens wearers must demonstrate a stable refraction (within ±0.50 D inmagnitude for both sphere and cylinder and within ±15° in axis) in both eyes, asdetermined by distance manifest refraction on two consecutive examination dates (both refractions performed at least 7 days apart) after discontinuation of contactlens wear (Rigid or Toric lenses discontinued for at least 2 weeks and soft contactlenses discontinued for at least 3 days prior to the first refraction used toestablish stability and through the day of surgery).

8. Subjects must require an IOL power from + 16.0 diopter (D) to + 24.0 D for each eye.

9. Subjects must be willing and able to comply with all treatment and follow-up studyvisits and procedures, and to undergo second eye surgery within 7-30 days of thefirst eye surgery.

Exclusion Criteria:

1. Subjects who have used an investigational drug or device within 30 days prior to theplanned first surgery date and/or will participate in another investigation duringthe 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 with conditions that increase the risk of zonular rupture during cataractextraction procedure that may affect the postoperative centration or tilt of thelens

4. Subjects who have uncontrolled glaucoma in either eye. Uncontrolled glaucoma isdefined as intraocular pressure (IOP)>21 mm Hg in spite of maximally toleratedmedications (with more than 3 topical drugs for IOP control).

5. Subjects with previous retinal detachment or clinically significant retinalpathology involving the macula in either eye.

6. Subjects who have proliferative or non-proliferative diabetic retinopathy in eithereye.

7. Subjects who have a congenital ocular anomaly (e.g., aniridia, congenital cataract)in either eye.

8. Subjects using any systemic or topical drug known to interfere with visualperformance, pupil dilation, or iris structure within 30 days of randomization (refer to the relevant attachment of the Study Reference Manual).

9. Subjects who have a history of chronic or recurrent inflammatory eye disease (e.g.,iritis, scleritis, iridocyclitis, or rubeosis iridis) in either eye.

10. Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration orother retinal disorders) that are expected to cause future visual acuity losses to alevel of 20/30 or worse in either eye.

11. Subjects who have had previous intraocular or corneal surgery in either eye thatmight confound the outcome of the investigation or increase the risk to the subject

12. Subjects with any infectious conjunctivitis, keratitis, or uveitis in either eye.

13. Subjects who have irregular astigmatism or skewed radial axis for either eye.

14. Subjects who cannot achieve a minimum pharmacologic pupil dilation of at least 5.0mm in both eyes.

15. Subjects who may be expected to require a combined or other secondary surgicalprocedure in either eye (note: corneal incisions intended specifically to reduceastigmatism are not allowed during the study).

16. Females of childbearing potential (those who are not surgically sterilized or atleast 12 months postmenopausal) are excluded from enrollment in the study if theyare currently pregnant or plan to become pregnant during the study, lactating orhave a condition associated with fluctuation hormones that could lead to refractivechanges. Females of childbearing potential must be willing to practice effectivecontraception for the duration of their participation in the study.

17. Subjects with any other serious ocular pathology or underlying systemic medicaldisease (e.g., uncontrolled diabetes) or circumstance that, based on theInvestigator's judgment, poses a concern for the subjects' safety, increases theoperative risk or could confound the results of the study.

18. Subjects who have current or previous usage of systemic medications that mayconfound the outcome or increase the risk to the subject based on the Investigator'sjudgement. For example; subjects on an alpha-1-selective adrenoceptor blocking agentor an antagonist of alpha 1A adrenoceptor (e.g., tamsulosin hyrdrochloride (Flomax®), Terazosin, Rapaflo or Cardura) or other medications with similar sideeffects (floppy iris syndrome).

19. Subjects who are expected to require retinal laser treatment