Indications for Use, Contraindications, Warnings, and Precautions
Page 16 of 314
Part Number: 0160-6411, Rev A, 02/2019
Software Release: cOS 5.00
the installation site IT administrator to identify, analyze, evaluate, and control these risks.
Subsequent changes to the installation site network could introduce new risks due to:
─ Changes to the network configuration
─ Connection of additional devices to the network
─ Disconnection of devices from the network
─ Update and/or upgrade of equipment connected to the network
The internal Hardware Security Appliance (HSA) installed on the
CATALYS®
System is
designed to mitigate these risks to an acceptable level. If system performance or speed
degrades when connected to a network, disconnect the
CATALYS®
System from the
network and contact
OPTIMEDICA
Service for assistance.
1.5 Adverse Effects
Complications associated with the
CATALYS®
System include mild Petechiae and subconjunctival
hemorrhage due to vacuum pressure of the
LIQUID OPTICS™
Interface suction ring.
Potential complications and adverse events 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, include:
Acute corneal clouding, age-related macular degeneration, amaurosis, anterior and/or pos-
terior capsule tear/rupture, astigmatism, capsulorrhexis notch during phacoemulsification,
capsulotomy/lens fragmentation or cut/incision decentration, cells in anterior chamber,
choroidal effusion, choroidal hemorrhage, conjunctival hyperemia/injection/erythema/ che-
mosis, conjunctivitis (allergic/viral), corneal abrasion/deepithelization/epithelial defect, cor-
neal edema, cystoid macula edema, Descemet’s detachment, decentered or dislocated
intraocular lens implant, diplopia, dropped or retained lens, dry eye/superficial punctate
keratitis, edema, elevated intraocular pressure, endothelial decompensation, floaters, glau-
coma, halo, inflammation, incomplete capsulotomy, intraoperative floppy iris syndrome, iris
atrophy/extrusion, light flashes, meibomitis, ocular discomfort (for example, pain, irritation,
scratchiness, itching, foreign body sensation), ocular trauma, petechiae, photophobia, pig-
ment changes/pigment in corneal endothelium/foveal region, pingueculitis, posterior cap-
sule opacification, posterior capsule rupture, posterior vitreous detachment, posteriorly
dislocated lens material, pupillary contraction, red blood cells in the anterior chamber (not
hyphema), residual cortex, retained lens fragments, retinal detachment, retinal hemor-
rhage, scar in Descemet’s membrane, shallowing or collapsing of the anterior chamber, scor-
ing of the posterior corneal surface, snailtrack on endothelium, steroid rebound effect,
striae in Descemet’s, subconjunctival hemorrhage, thermal injury to adjacent eye tissues,
toxic anterior shock syndrome, vitreous in the anterior chamber, vitreous band, vitreous
loss, wound dehiscence, wound or incision leak, zonular dehiscence.
