Indications for Use
The IntraLase FS and iFS Lasers are 21 CFR 1040 class IIIb ophthalmic surgical lasers with the following indications for use:
In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea
In patients undergoing ophthalmic surgery or other treatment requiring Arcuate cuts/incisions in the cornea, penetrating and/or
Intrastromal
In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for
placement of corneal ring segments
In lamellar keratoplasty and corneal harvesting
In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of
the cornea
In the creation of a lamellar cut/resection of the cornea for lamellar keratoplasty and for the creation of a penetrating
cut/incision for penetrating keratoplasty.
The IntraLase FS and iFS Laser delivery systems are used in conjunction with a sterile disposable IntraLase Patient Interface,
consisting of pre-sterilized suction ring assemblies and pre-sterilized applanation lenses, intended for single-use.
The IntraLase FS and iFS Lasers should only be operated by, or under the direct supervision of a trained physician with certification in
laser safety and in the use of the IntraLase FS Laser.
Flap Contraindications
Lamellar resection for the creation of a corneal flap using the IntraLase FS or iFS Lasers is contraindicated if any of the following
conditions exist. Potential contraindications are not limited to those included in this list:
Corneal edema
Corneal lesions
Hypotony
Glaucoma
Existing corneal implant
Keratoconus
IntraLase Enabled Keratoplasty (IEK) Contraindications
Contraindications to use of the IntraLase FS or iFS Lasers for the indications described for the IEK procedure include:
Any corneal opacity adequately dense to obscure visualization of the iris;
Descemetocoele with impending corneal rupture;
Previous corneal incisions that might provide a potential space into which the gas produced by the procedure can escape; and
Corneal thickness requirements that are beyond the range of the system.
The following conditions should also be considered when using the IntraLase FS or iFS Lasers for IEK:
Severe corneal thinning
Subjects with pre-existing glaucoma
A history of steroid responsive rise in intraocular pressure
Preoperative intraocular pressure greater than 21 mmHg in the operative eye
Important Safety Information
Subjects with more than 1200 ?m corneal thickness at the 9 mm peripheral zone
Active intraocular inflammation
Active ocular infection
Warnings
FS and iFS Lasers
The performance of surgical or laser alignment procedures, operation of controls or any other adjustments other than those
specified herein may result in hazardous conditions for both patients and personnel.
While the risk of fire is extremely low, the IntraLase FS or iFS Laser should not be operated in the presence of flammable
anesthetics, volatile substances, or oxygen flow lines.
Only certified accessories that conform to National and International standards (i.e., IEC 60950-1, IEC 60601-1 or similar)
should be connected to the input/output ports on the FS Laser.
High voltage electrical circuits are accessible if the console panels are removed. Only trained AMO service representatives
should attempt to open the console panels. Serious injury or death may occur as a result of exposure to electrical circuits in
the unit interior.
Do not use cell phones, pagers, or radio frequency devices of any kind in the same room as the IntraLase FS or iFS Laser.
If an articulating chair is used in conjunction with the FS or iFS Laser system, take proper precautions to avoid any unintended
movement of the chair toward the laser system. Refer to the specific operating instructions provided by the manufacturer of the
articulating chair.
To ensure the proper operation of the Z-Verifier safety features, use the joystick to applanate and to activate the green eye
contact LED. Do not lift and place the objective on the eye in lieu of using the joystick.
The suction ring assembly must be disengaged from the patient's cornea before using the Home button.
Check all treatment parameters for accuracy.
Only trained AMO service representatives should perform unpacking, installation, and servicing of the IntraLase FS or iFS
Lasers. Covers must not be removed by anyone other than AMO service representatives. Accidental contact with the high
voltage electrical circuits in the interior of the IntraLase FS or iFS Laser consoles may result in serious injury or death.
Ocular exposure to collimated beams contained in the console interior can produce retinal damage.
The UPS (Uninterruptable Power Supply) is designed for exclusive use with the FS or iFS Laser system. Do not connect any
other electrical device to the UPS system.
Check all parameters for accuracy before proceeding to the next phase.
Patient procedures performed with an improperly operating IntraLase FS or iFS Laser may produce poor or otherwise
unacceptable resections, or may result in complications.
Use of this laser system allows laser surgical incisions to be created up to 1200 ?m deep. Additionally, resection patterns can
be freely adjusted to create various geometric shapes. It is advised that the user check all treatment parameters, and then
verify the pattern outline http://www.youtube.com/watch?v=HFRm6H6MB_8/ a physician or other licensed eye care
practitioner.
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