2.2.7. Pregnant or nursing mothers and females of childbearing potential not practicing a reliable and medically acceptable method of birth control. 2.2.8. Any clinically significant, serious or severe medical or psychiatric condition that may increase the risk associated with study participation or study device implantation or may interfere with the interpretation of study results. 2.2.9. Participation in (or current participation) any investigational drug or device trial within the previous 30 days prior to the start date of this trial. 2.2.10. Intraocular conventional surgery within the past three months or intraocular laser surgery within one month in the operated eye. 2.2.11. Other ocular surgery at the time of the cataract extraction.