Indications for Use, Contraindications, Warnings, and Precautions
Part Number: 0160-6411, Rev A, 02/2019
Page 15 of 314
Software Release: cOS 5.00
• After removal of the capsulotomy disc, if any capsulotomy thread remnant (less than 50
μm nominal thickness) is seen, do not remove it. Removal of a capsulotomy thread
remnant could potentially cause or contribute to an anterior capsule tear and/or a non-
circular, irregularly-shaped capsulotomy.
• The
LIQUID OPTICS™
Interface is intended for single use only.
• Do not use the
LIQUID OPTICS™
Interface after the expiration date on the package.
• Inspect all packaging for the
LIQUID OPTICS™
Interface prior to use. Do not use if the
sterile barrier has been breached, if the package is damaged in any way, or if the device
has been dropped.
• Do not attempt to capture the disposable lens if the fluid reservoir is full. After suction
has been established, periodically verify and do not allow the maximum volume of fluid
to fill beyond where the tubing enters the fluid reservoir. Refer to
on page
for an illustration of the highest acceptable level of fluid. If the fluid reservoir does
become full, replace the entire
LIQUID OPTICS™
Interface before continuing.
• The touchscreen control panel must be kept dry at all times.
• Use blunt dissection to separate the edges of corneal incisions. Avoid using sharp
instruments for manipulating the corneal incision, to preserve the original incision
geometry and to prevent unintended dissection.
• Full-thickness corneal cuts or incisions should be performed with instruments and
supplies on standby, to seal the eye in case of anterior chamber collapse or fluid leakage.
• Patients who will undergo full-thickness corneal incisions with the
CATALYS®
System
should be given the same standard surgical preparation as used for patients undergoing
cataract surgery for the removal of the crystalline lens.
• During intraocular surgery on patients who have undergone full-thickness corneal
incisions with the
CATALYS®
System, care should be taken if an eyelid speculum is used, to
limit pressure from the speculum onto the open eye.
• Patients who will be transported between the creation of a full-thickness corneal incision
and the completion of the intraocular surgery should have their eye covered with a sterile
rigid eye shield, to avoid inadvertent eye injury during transport.
• Patients must be able to lie flat and motionless in a supine position.
• Patients must be able to tolerate local or topical anesthesia.
• In the event a corneal incision is interrupted and resumed, do not attempt to force the
incision open if it is not blunt dissectible. If the corneal incision is not blunt dissectible,
use a bladed instrument to create a separate corneal incision to continue with the
procedure.
• Do not connect anything other than a USB flash drive to the
CATALYS®
System USB ports.
• Connection of the
CATALYS®
System to a customer network that includes other
networked equipment could result in previously unidentified risks. During system
installation,
OPTIMEDICA
-trained personnel will review the installation site network with
