See Indications and Important Safety Information Below for the
CATALYS® Precision Laser System
Rx Only
INDICATIONS: The OptiMedica
CATALYS® Precision Laser System 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.
CONTRAINDICATIONS: Should not be
used in patients with corneal ring and/or inlay implants, severe
corneal opacities,
corneal abnormalities, significant corneal edema or
diminished aqueous clarity that obscures OCT imaging of the
anterior lens capsule, patients younger than 22
years of age, descemetocele with impending corneal rupture, and any
contraindications to cataract surgery.
PRECAUTIONS: The CATALYS® System
has not been adequately evaluated in patients with a cataract greater
than
Grade 4 (via LOCS III); therefore no conclusions
regarding either the safety or effectiveness are presently available.
ADVERSE EFFECTS: Complications
include mild Petechiae and subconjunctival hemorrhage due to vacuum
pressure
of the LIQUID OPTICS Interface suction ring.
Potential complications and adverse events include those generally
associated
with the performance of capsulotomy and lens
fragmentation, or creation of a partial-thickness or full-thickness
cut or incision of the cornea.
CAUTION: Should be used only by qualified physicians who have extensive knowledge of the use of this device and
have been trained and certified by Abbott Medical Optics/OptiMedica.
ATTENTION: Reference the labeling for a complete listing of Indications and Important Safety Information.
© 2016 Abbott Medical Optics Inc. OPTIMEDICA and CATALYS are trademarks
owned by or licensed to Abbott Laboratories, its subsidiaries or affiliates.
PP2015CT1096 |