The purpose of the study is to compare femtosecond laser-assisted capsulotomy to manual capsulorhexis in patients with intumescent cataracts. An intumescent cataract is defined as a cataract with a pressurized capsular bag.

Inclusion Criteria:

• Willing to undergo cataract surgery.
• Able to lie flat in a supine position.
• Able to understand and willing to sign the Informed Consent Form (ICF).
• Presenting with intumescent white cataract, with a liquid pressurized bag and a milky, liquid cortex.
• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

• Pregnant or lactating mothers.
• Corneal disease that precludes application of the cornea or transmission of laser light at 1030 nanometer (nm) wavelength.
• Corneal opacity that would interfere with the laser beam.
• Presence of blood or other material in the anterior chamber.
• Hypotony or presence of corneal implant.
• Poorly dilating pupils.
• Condition which would cause inadequate clearance between the intended capsulotomy depth and the endothelium.
• Residual, recurrent, active ocular or eye lid disease, including any corneal abnormality.
• Any contraindication to cataract surgery.
• Other protocol-specified exclusion criteria may apply.

This analysis population includes subjects who signed an informed consent form, were randomized, and underwent the removal of an intumescent cataract with subsequent IOL implantation (Intent-to-Treat (ITT)).

Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 75 days). AEs are reported as pre-treatment and treatment-emergent.

An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational product (test or control article). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.