Investigation of the Safety and Effectiveness of Monofocal Toric Intraocular Lens (IOL)

Exclusion Criteria

• •· Subjects with irregular corneal astigmatism in the study eye (Note: corneal incisions intended to reduce astigmatism are not permitted)
• •* Subjects with clinically significant corneal pathology potentially affecting corneal topography in the study eye.
• •* Subjects with a traumatic cataract in the study eye.
• •* Subjects with uncontrolled glaucoma in the study eye.
• •* Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that are predicted to cause future acuity losses to a level of 0.2 logMAR or worse in the study eye.
• •* Subjects with conditions associated with increased risk of zonular rupture during the cataract extraction procedure which may affect the postoperative centration or tilt of the lens in the study eye.
• •* Significant anterior segment pathology that might increase intraoperative risk or compromise IOL stability (e.g., pseudoexfoliation syndrome) in the study eye.
• •* Reasonably expected to require secondary ocular surgical intervention or laser treatment other than YAG capsulotomy in study eye during the study participation period.
• •* Presence of one or more clinically significant corneal abnormalities in study eye, including corneal dystrophy, irregularity, or edema.
• •* Previous intraocular, corneal, or retinal detachment surgery, including corneal transplant, LASIK, astigmatic keratotomy and limbal relaxing incisions in the study eye.
• •* Clinically significant ocular inflammation or infection present ≤ 30 days in either eye prior to the Preoperative Visit.
• •* Subjects with potential BCDVA of 20/200 or worse in the fellow eye.
• •* Subjects with a difference of greater than 0.50 D of corneal astigmatism as measured with the IOL master/Lenstar/Argos and the topographer in the study eye using vector analysis.
• •* Presence or history of one or more severe/serious ocular conditions (e.g., glaucoma, uveitis, ocular infection, severe dry eye) in the study eye, or any other unstable medical condition (e.g., uncontrolled diabetes) that in the opinion of the Investigator would put the subject's health at risk, confound the results of the study and/or prevent the subject from completing all study visits.
• •* Use of medications known to interfere with visual performance, pupil dilation, or iris structure ≤ 30 days prior to the Preoperative Visit.
• •* Participation in any study of an investigational, interventional product within 30 days prior to the Preoperative Visit or at any time during the study period.
• •* Pregnant or nursing females