SUMMARY OF SAFETY INFORMATION

The FS and iFS Laser systems are ophthalmic surgical lasers indicated for use in patients undergoing surgery or treatment requiring the initial lamellar resection of the cornea.  Contraindications may include corneal edema, glaucoma, and keratoconus.  Risks and complications may include corneal pain, flap tearing, and epithelial ingrowth.  Consult with your eye care professional for a complete listing of contraindications and risks.  US Federal law restricts this device to sale, distribution, and use by or on the order of a physician or other licensed eye care practitioner.

IMPORTANT SAFETY INFORMATION

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 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 keratomileusis in situ for the correction of myopia
• 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
• Subjects with more than 1200 µm 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 µm 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 in the graphical display, before proceeding to the next phase.
• Setting the posterior depth too deep during could result in injury to other intraocular structures.
• Operation of this system, with the keratoplasty application, requires that the user provide a calibrated corneal thickness measurement device.
• Caution must be taken to remove suction prior to removing applanation to avoid injury to intraocular structures.

Patient Interface

• The Patient Interface disposables should not be reused or re-sterilized.
• Used IntraLase Patient Interface assemblies should be treated as medical waste. Use and disposal of the IntraLase Patient Interface is detailed in the IntraLase Patient Interface Directions for Use (DFU).
• The applanation lens becomes etched by the laser during the side-cut procedure and MUST NOT be re-used. Laser light will not effectively permeate an etched lens, and the precision of the laser will be altered.
• To preserve sterility, open the disposable tray while wearing sterile, powder free surgical gloves and complete the following steps.
• Do not attempt to use a damaged Patient Interface.
• If the suction ring assembly clip fails to disengage, or if it prematurely disengages, do not attempt use.

Flap Complications

Possible complications resulting from Lasik surgery include (potential complications are not limited to those included in this list):

• Corneal edema
• Corneal pain
• Epithelial ingrowth
• Epithelial defect
• Infection
• Flap de-centration
• Incomplete flap creation
• Flap tearing or incomplete lift-off
• Free cap
• Photophobia
• Corneal inflammation, such as diffuse lamellar keratitis (DLK), corneal infiltrates, and iritis
• Thin or thick flaps
• Flap striae

The following sporadically reported visual symptoms may occur following LASIK flap creation with the IntraLase FS or iFS Laser.

Transient Light Sensitivity Syndrome (TLSS)

Transient Light Sensitivity Syndrome is characterized by symptoms of mild to severe light sensitivity which manifests between two and six weeks postoperatively. Patients experience no decrease in uncorrected or best spectacle-corrected visual acuity. The incidence of this sensitivity is observed in approximately 1% of patients who undergo flap creation with the IntraLase FS laser. Patients respond to the use of hourly topical steroids such as Pred Forte, and most report improvement within one week of treatment.

Peripheral Light Spectrum (PLS)

Peripheral Light Spectrum (PLS) is a temporary phenomenon whereby patients report the perception of a spoke-like spectrum of light in the periphery of their vision. PLS has no clinical examination findings and no effect on visual acuity; however the potential diffractive effects may be bothersome to some patients. Reported in only 0.03% of cases, the onset of symptoms occurs during the immediate postoperative period, and typically resolves within three months but may be slightly persistent in rare cases. The visual impact of PLS is clinically inconsequential for the vast majority of patients.

US Federal law restricts this device to sale, distribution, and use by or on the order of a physician or other licensed eye care practitioner.