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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.

The product may contain mercury. Please dispose accordingly to state, local or federal laws.

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 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.

The product may contain mercury. Please dispose accordingly to state, local or federal laws.

IntraLase FS Laser

The Technology Behind LASIK Success

How does AMO's IntraLase™ FS Technology contribute to LASIK success? By delivering biomechanical superiority, excellent visual acuity, and unmatched safety. This innovative technology is also well suited for creating uniquely shaped corneal incisions for corneal transplant surgery.

How IntraLase™ Fits Within LASIK

There's Only One IntraLase™ FS Laser System

Increasingly, successful LASIK procedures have one thing in common — they use AMO's IntraLase™ FS Laser System. IntraLase™ FS Technology clearly delivers clinical advantages to enhance your practice.

  • Our 4th-generation laser is designed as a primary laser for LASIK procedures and advanced corneal surgery procedures
  • 60 kHz performance delivers microkeratome speed and laser precision
  • Better biomechanical stability vs. a microkeratome (1)
  • Lower induced high-order aberrations vs. a microkeratome (2)
  • Better refractive outcomes vs. a microkeratome (2)

*Through three months postoperative

  1. Alió JL, Ortiz D, Piñero D. Flap biomechanics with femtosecond and mechanical microkeratomes. Data presented at: European Society of Cataract and Refractive Surgeons; September 10-14, 2005; Lisbon, Portugal.
  2. Durrie DS, Kezirian GM. Femtosecond laser versus mechanical keratome flaps in wavefront-guided in situ keratomileusis: prospective contralateral eye study. J Cataract Refract Surg. 2005;31(1):120-126.

Information for consumers

For consumer information on iLASIK™ please visit

http://www.ilasik.com

One Million Reasons And Counting

At a nearly unprecedented level, LASIK has become a trusted way for people to improve their functional vision. And judging by the numbers, the IntraLase Method, using AMO's IntraLase™ FS Technology, has become an integral part of today's advanced LASIK procedure. With well over 1 million procedures completed to date, IntraLase™ FS Technology is clearly in the DNA of your successful practice. This seemingly genetic link between IntraLase™ FS Laser System and your LASIK practice exists because:

  • Patients want all-laser LASIK, and we're the all-laser pioneers
  • Surgeons believe in the safety, effectiveness and profitability profile of the IntraLase™ FS laser
  • The future of refractive surgery hinges on the innovative application of scientific breakthroughs, and IntraLase™ FS Technology is at the forefront

Biomechanically Superior Flap Creation

Maintaining the integrity of the corneal biomechanics is a critical element in the success of the refractive procedure — and only AMO IntraLase™ FS Laser System delivers unmatched control over flap diameter, depth, centration and morphology, resulting in an unprecedented combination of potential advantages, including:

  • Controlled Flap Structure
    • Precisely centered, accurately sized flaps; programmable hinge placement1
    • Flap dimensions designed based on patient factors, such as corneal thickness, steepness, diameter and pupil position
    • Precise control of flap dimensions helps avoid the peripheral lamellar structure, vital to the biomechanical stability of the cornea2
  • Uniform Flap Thickness
    • Uniformly thin, planar flaps3
    • Smooth, evenly hydrated, stromal morphology4
    • Reproducible flap thicknesses with profiles that are significantly superior to those achieved by mechanical means (p<0.001)4
    • Maximized residual stromal beds
  • Superior Visual Outcomes
    • Rapid visual recovery
      • Day 1: UCVA 20/16 or better in 70% of patients (n=199)5
      • Month 1: Increased contrast sensitivity at all spatial frequencies vs. baseline (n=88)6
    • Better quality of vision
      • Eyes treated with the IntraLase FS Laser System had fewer visual disturbances (haze, glare, sensitivity), less pain, and less dryness than a microkeratome6



INTRALASE FS (9x)
Zyoptix XP (9x)
ZYOPTIX XP (9x)

INTRALASE FS (135x)
Zyoptix XP (135x)
ZYOPTIX XP (135x)

INTRALASE FS (300x)
Zyoptix XP (300x)
ZYOPTIX XP (300x)


References:
  1. Data on file, IntraLase Corp.
  2. Prof. John Marshall. Sub-Bowman's Keratomileusis vs. PRK. Data presented at: Winter European Society of Cataract and Refractive Surgeons; February 2-4, 2007.
  3. Binder PS. Flap dimensions created with the IntraLase FS Laser. J Cataract Refract Surg. 2004;30(1):26-32.
  4. Kezirian GM, Stonecipher KG. Comparison of the IntraLase femtosecond laser and mechanical keratomes for laser in situ keratomileusis. J Cataract Refract Surg. 2004;30(4):804-811.
  5. Tanzer DJ, Schallhorn S, Brown MC, et al. Comparison of femtosecond vs. mechanical keratome in wavefront-guided LASIK. Data presented at: American Society of Cataract and Refractive Surgery Symposium; April 15-20, 2005; Washington, DC.
  6. Durrie D. A randomized, prospective clinical study of LASIK performed with the IntraLase FS laser vs. mechanical microkeratome. Data presented at: American Academy of Ophthalmology; October 23-26, 2004; New Orleans, LA.

Faster Visual Acuity Than Surface Treatments

In a recent study (Sub-Bowman's Keratomileusis with IntraLase™ FS Laser System vs. PRK), IntraLase treated eyes demonstrated clinically and statistically better visual acuities (uncorrected and best corrected) through one month postop compared to surface treatment.1

  • Uncorrected Vision
    • Through one week postop, eight times more IntraLase eyes achieved 20/20 or better uncorrected vision compared to PRK eyes1
    • Superiority continued at one month, where 45% more IntraLase eyes achieved 20/20 or better uncorrected vision compared to PRK eyes1
  • Best Corrected Vision
    • Clinically and statistically significant improvement through one month with LASIK with the IntraLase Method over PRK when comparing baseline BCVA and postop BCVA1
    • At one month, more than twice as many IntraLase eyes showed BCVA gain compared to PRK eyes1


 

 

  1. Data on file, IntraLase Corp.

Precision Technology For A Safer LASIK Experience

By replacing the blade commonly used for corneal flap creation with a femtosecond laser, AMO® has made LASIK eye surgery safer than ever before. The IntraLase™ FS Laser System delivers micron-level accuracy 100% greater1,2 than a microkeratome for more accurate and consistent flap thickness — which is critical for a successful LASIK outcome.

Retrospective analysis comparing LASIK results with IntraLase™ FS Technology versus the two leading microkeratomes demonstrated that IntraLase™ FS Laser System performed better in three areas important to LASIK results and safety: flap thickness, induced astigmatism, and cell injury.3 There are fewer flap-related complications with the IntraLase Method:*4

  • Minimal risk of sight-threatening events (free caps, globe penetration, buttonhole flaps, decentered flaps, and/or incomplete cuts)
  • No risk of corneal abrasion
  • Reduced risk of dry eye

*Only the IntraLase™ FS Laser System can be used to perform the IntraLase Method.

  1. Wang M. Femtosecond technology: Is now the time to buy? Refractive Eyecare for Ophthalmologists. May 2003;5:7.
  2. Talamo JH. Optimizing flap outcomes with the IntraLase™ FS laser. Ophthalmol Management. May 2004.
  3. Kezirian GM, Stonecipher KG. Comparison of the IntraLase™ femtosecond laser and mechanical keratomes for laser in situ keratomileusis. J Cataract Refract Surg. 2004;30(4):804-811.
  4. Will B, Kurtz RM. IntraLase™ is best. In: Probst LE, ed. LASIK: Advances, Controversies, and Custom. Thorofare, NJ: SLACK; 2004:397-402.

Innovative-Shaped Corneal Incisions

IntraLase™ enabled keratoplasty gives surgeons the ability to precisely create uniquely shaped corneal incisions — opening a new era in corneal transplantation and delivering the potential for faster healing and improved visual recovery. Leading corneal surgeons have demonstrated that this technology advancement enables:

  • Surgeons to create straight, angled and arcuate incisions within the cornea
  • Multiplanar custom incisions with hermetic sealing properties that require less suture tension
    • Less suture tension can result in less astigmatism1
    • Multiplanar custom incisions provide larger wound surface area for stronger healing
  • Laser resectioning that produces more rapid healing1
  • Earlier suture removal and rapid visual rehabilitation1
Create Customized Incisions With Advanced Edge Profiles
Mushroom incision profile

The mushroom-shaped incision preserves more host endothelium than the traditional trephine approach.1
Top-hat incision profile

The top-hat-shaped incision allows for the transplantation of large endothelial surfaces.1
Zig-zag incision profile

The zig-zag-shaped incision provides a smooth transition between host and donor tissue and allows for a hermetic wound seal.1

Establish Secure Grafts, Requiring Less Suture Tension1
1 week after surgery
1 week after surgery
3 months after surgery
3 months after surgery
6 months after surgery
6 months after surgery
Early experience indicates that IEK incisions create less irritation, form hermetic wound seals, and produce crystal-clear corneas at 1, 3, and 6 months. In addition, all sutures were removed before 6 months vs. 1 year with standard trephine techniques.2

Reduce the Incidence of Induced Astigmatism
Zig-zag incision
Zig-zag incision
The zig-zag-shaped incision has shown a smooth corneal contour immediately after surgery, with less distortion of the corneal optics and less astigmatism.1
IEK 3 months
after surgery
IEK 3 months after surgery
IEK result at 3 months after surgery = 0.5 diopter of astigmatism.1
Trephine 1 year
after surgery
Trephine 1 year after surgery
Typical result with standard trephine-cut PKP at 1 year after surgery = 8 diopters.1


  1. Steinert RF. Femtosecond laser corneal surgery. Data presented at: American Academy of Ophthalmology, November 11-13, 2006; Las Vegas, NV.
  2. Photos and personal communication, Francis W Price, Jr, MD.

Education, Practice Development & Customer Service resources


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.

The product may contain mercury. Please dispose accordingly to state, local or federal laws.