Johnson & Johnson Surgical Vision Veritas, Operator'S Manual

Page: 14 / 270

Intended Use / Indications Z370584 Rev. D
1-4
Introduction
NOTE: Provides background information to clarify a particular step or procedure.
Intended Use / Indications
The VERITAS Vision System is a modular ophthalmic microsurgical system that facilitates
anterior segment (cataract) surgery. The modular design allows the users to configure the
system to meet their surgical requirements.
Contraindications
Any pre-existing patient condition/s that the health care provider determines to be a
contraindication to cataract surgery.
Undesirable Side Effects
Complications that may be associated with the VERITAS Vision System include
• corneal burn
• infection/inflammation
• corneal edema
• broken capsule
Intended Patient
Adult patients with cataracts or adult patients undergoing anterior segment ophthalmic
surgery (e.g., removal of the crystalline lens).
NOTE: Pregnant or nursing women were not included in the clinical trial(s) conducted.
Intended User
The JJSV Phacoemulsification System is intended for use by an ophthalmologist and support
staff operating under the direction of the surgeon.
IMPORTANT:
Identifies instructions important to the proper operation of the device.