A Post-Market Clinical Follow-Up on Safety and Performance of the Ophthalmic Viscoelastic Devices Eyefill SC and Eyefill MB

Inclusion Criteria:

• Adult subjects scheduled for cataract surgery with im-plantation of a posteriorchamber intraocular lens;

• Signed informed consent;

• Availability, willingness, ability, and sufficient cognitive awareness to complywith examination procedures

Exclusion Criteria:

• Known hypersensitivity to sodium hyaluronate;

• Corneal endothelial cell density <1500 cells/mm2;

• Corneal abnormalities;

• Cataract density of grade 4+;

• Previous intraocular or corneal surgery;

• Chronic or recurrent inflammatory eye diseases (e.g., iritis, scleritis,iridocyclitis, or rubeosis iridis);

• Clinically significant, uncontrolled glaucoma with expected negative impact onvisual acuity outcomes;

• Ongoing systemic or ocular steroid therapy;

• Diagnosed degenerative visual disorders (e.g. macular degeneration or other retinalor optic disorders) that are predicted to cause future acuity loss to 20/30 or worsein one or both eyes;

• Active ocular or systemic infection (bacterial, viral, or fungal), including fever

• Subjects who may be expected to require a combined or other secondary surgicalprocedure

• Females of childbearing potential (those who are not surgically sterilized or notpostmenopausal for at least 12 months) if they meet one of the following conditions:Pregnant, lactating or unwilling to use effective birth control over the course ofthe study;

• Concurrent or previous (within 30 days) participation in another drug or deviceinvestigation.