Iridex PASCAL Synthesis - Introduction; Intended Use; Indications for Use

PASCAL
®
Synthesis Ophthalmic Scanning Laser Systems Page 5 of 141
88292-EN, Rev D
INTRODUCTION
INTENDED USE / INDICATIONS FOR USE
PASCAL
®
Synthesis Ophthalmic Scanning Laser System is a laser system console with an
integrated slit lamp. The system connects to the slit lamp to enable laser energy to be
delivered through the slit lamp illumination path. The system may be used for standard single
shot photocoagulation and laser scanning patterns.
The system enables the physician to deliver multiple laser spots with a single footswitch
depression by automating the emission of laser light. The aiming beam displays the pattern,
allowing the physician to place it in the appropriate location.
The system is intended for use by trained Ophthalmologists for diagnosis and treatment of
ocular pathology in both the posterior and anterior segments. Intended for use in the
posterior segment to perform retinal photocoagulation, panretinal photocoagulation, focal
photocoagulation and grid photocoagulation for vascular and structural abnormalities of the
retina and choroid including:
(532 nm)
• proliferative and non-proliferative diabetic retinopathy
• macular edema
• choroidal neovascularization associated with wet age-related macular degeneration
• age-related macular degeneration
• lattice degeneration
• retinal tears and detachments (577 nm)
• proliferative and non-proliferative diabetic retinopathy
• macular edema
• choroidal neovascularization associated with wet age-related macular degeneration
• age-related macular degeneration
• lattice degeneration
• retinal tears and detachments
Intended for use in the treatment of ocular pathology in the anterior segment including: (532
nm and 577 nm)
• iridotomy
• trabeculoplasty