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O P H T H A L M O L O G Y
Food and Drug Administration's
510(k) clearance for use in
Caution:
United States Federal Law restricts this device to sale and use by or on the order of a physician or licensed
eye care practitioner.
Indication:
The LenSx® Laser is indicated for use in patients undergoing cataract surgery for removal of the crystalline
lens. Intended uses in cataract surgery include anterior capsulotomy, phacofragmentation, and the
creation of single plane and multi-plane arc cuts/incisions in the cornea, each of which may be performed
either individually or consecutively during the same procedure.
Restrictions:
cataract surgery and for purchase
in the U.S.:
• Alcon Laboratories' LenSx Laser
(www.lensxlasers.com)
• Bausch & Lomb's Victus
Contraindications:
Femtosecond Laser Platform
wavelength
(tinyurl.com/b6dqsov)
the endothelium (applicable to capsulotomy only)
• the LensAR Laser System
procedure can escape
of the system
(www.lensar.com)
any corneal abnormality (for example, recurrent corneal erosion, severe basement membrane
disease)
• Optimedica's Catalys Precision
Laser System
Attention:
Warnings:
The LenSx® Laser System should only be operated by a physician trained in its use.
(www.optimedica.com)
According to industry observers,
the systems differ in several techni-
extraction.
Precautions:
cal aspects, including their lasers'
AEs/Complications:
"behavior" (beam profiles, pulse
width, duration and repetition rate,
for instance); their imaging capabilities for scanning and measuring
ocular anatomy; and how the laser
apparatus comes in contact, or
"docks," with the corneal surface
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O U T PAT I E N T S U R G E R Y M A G A Z I N E O N L I N E | F E B R U A R Y 2013
