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EW Chicago 2012 11 Other considerations: The following conditions should also be considered: severe corneal thinning; subjects with pre-existing glaucoma; a history of steroid responsive rise in intraocular pressure; preoperative intraocular pressure greater than 21 mm Hg in the operative eye; subjects with more than 1,000 μm corneal thickness at the 9 mm peripheral zone; active intraocular inflammation; and active ocular infection. Complications: Possible complications that may result from flap cutting include (potential complications are not limited to those included in this list): corneal edema; corneal pain; epithelial ingrowth; epithelial infection; flap decentration; incomplete flap creation; flap tearing or incom- plete lift-off; free cap; photophobia; corneal inflammation, such as diffuse lamellar keratitis (DLK), corneal infiltrates and iritis; thin or thick flaps; flap striae; and corneal ectasia (secondary kerato- conus). Warnings: Any treatment with the WaveLight FS200 is not recommended in patients who have: systemic diseases likely to affect wound healing, such as connective tissue disease, insulin dependent diabetes, severe atopic disease or an immunocompromised status; a history of Herpes simplex or Herpes zoster keratitis; significant dry eye that is unresponsive to treatment; severe allergies; and a history of glaucoma or ocular hypertension. We recommend discussing the following potential complications of this device with your patients: Transient Light Sensitivity Syndrome (TLSS): Transient Light Sensitivity Syndrome is charac- terized by symptoms of mild to severe light sensitivity that manifests between two and six weeks postoperatively. Patients experience no decrease in uncorrected or best spectacle-corrected visual acuity. The incidence of this sensitivity was observed in approximately 1% of patients who undergo flap creation with a femtosecond laser. 3 Patients respond to the use of hourly topical steroids such as Pred Forte (Allergan), and most report improvement within one week of treat- ment. Peripheral Light Spectrum (PLS): Peripheral Light Spectrum 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 po- tential diffractive effects may be bothersome to some patients. Reported in only a small amount 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. 1. Accutane is a registered trademark of Hoffmann-La Roche Inc. 2. Cordarone is a registered trademark of Sanofi. 3. FDA Database Research Results Feb. 05, 2009. WaveLight Excimer Laser Systems This information pertains to all WaveLight Excimer Laser Systems, including the WaveLight ALLEGRETTO WAVE, the ALLEGRETTO WAVE Eye-Q , and the WaveLight EX500. Caution: Federal (U.S.) law restricts the WaveLight Excimer Laser Systems to sale by or on the order of a physician. Only practitioners who are experienced in the medical mangement and surgical treatment of the cornea, who have been trained in laser refractive surgery (including laser calibration and operation) should use a WaveLight Excimer Laser System. Indications: FDA has approved the WaveLight Excimer Laser for use in laser-assisted in situ keratomileusis (LASIK) treatments for: • the reduction or elimination of myopia of up to –12.0 DS and up to 6.0 D of astigmatism at the spectacle plane; • the reduction or elimination of hyperopia up to +6.0 DS with and without astigmatic refractive errors up to 5.0 D at the spectacle plane, with a maximum manifest refraction spherical equiv- alent of +6.0 D; • the reduction or elimination of naturally occurring mixed astigmatism of up to 6.0 D at the spectacle plane; and • the wavefront-guided reduction or elimination of myopia of up to –7.0 DS and up to 3.0 D of astigmatism at the spectacle plane. The WaveLight Excimer Laser Systems are only indicated for use in patients who are 18 years of age or older (21 years of age or older for mixed astigmatism) with documentation of a stable manifest refraction defined as ≤0.50 D of preoperative spherical equivalent shift over one year prior to surgery, exclusive of changes due to unmasking latent hyperopia. Contraindications: The WaveLight Excimer Laser Systems are contraindicated for use with patients who: • are pregnant or nursing; • have a diagnosed collagen vascular, autoimmune or immunodeficiency disease; • have been diagnosed with keratoconus or if there are any clinical pictures suggestive of keratoconus; or • are taking isotretinoin (Accutane*) and/or amiodarone hydrochloride (Cordarone*). Warnings: The WaveLight Excimer Laser Systems are not recommended for use with patients who have: • systemic diseases likely to affect wound healing, such as connective tissue disease, insulin dependent diabetes, severe atopic disease or an immunocompromised status; • a history of Herpes simplex or Herpes zoster keratitis; • significant dry eye that is unresponsive to treatment; • severe allergies; or • an unreliable preoperative wavefront examination that precludes wavefront-guided treatment. The wavefront-guided LASIK procedure requires accurate and reliable data from the wavefront examination. Every step of every wavefront measurement that may be used as the basis for a wavefront-guided LASIK procedure must be validated by the user. Inaccurate or unreliable data from the wavefront examination will lead to an inaccurate treatment. Precautions: The safety and effectiveness of the WaveLight Excimer Laser Systems have not been established for patients with: • progressive myopia, hyperopia, astigmatism and/or mixed astigmatism, ocular disease, previous corneal or intraocular surgery, or trauma in the ablation zone; • corneal abnormalities including, but not limited to, scars, irregular astigmatism and corneal warpage; • residual corneal thickness after ablation of less than 250 microns due to the increased risk for corneal ectasia; • pupil size below 7.0 mm after mydriatics where applied for wavefront-guided ablation planning; • history of glaucoma or ocular hypertension of >23 mm Hg; • taking the medication sumatriptan succinate (Imitrex*); • corneal, lens and/or vitreous opacities including, but not limited to cataract; • iris problems including, but not limited to, coloboma and previous iris surgery compromising proper eye tracking; or • taking medications likely to affect wound healing including (but not limited to) antimetabolites. In addition, safety and effectiveness of the WaveLight Excimer Laser Systems have not been established for: • treatments with an optical zone <6.0 mm or >6.5 mm in diameter, or an ablation zone >9.0 mm in diameter; or • wavefront-guided treatment targets different from emmetropia (plano) in which the wavefront calculated defocus (spherical term) has been adjusted. In the WaveLight Excimer Laser System clinical studies, there were few subjects with cylinder amounts >4 D and ≤6 D. Not all complications, adverse events, and levels of effectiveness may have been determined for this population. Pupil sizes should be evaluated under mesopic illumination conditions. Effects of treatment on vision under poor illumination cannot be predicted prior to surgery. Adverse events and complications Myopia: In the myopia clinical study, 0.2% (2/876) of the eyes had a lost, misplaced, or misaligned flap reported at the 1 month examination. The following complications were reported 6 months after LASIK: 0.9% (7/818) had ghosting or double images in the operative eye; 0.1% (1/818) of the eyes had a corneal epithelial defect. Hyperopia: In the hyperopia clinical study, 0.4% (1/276) of the eyes had a retinal detachment or retinal vascular accident reported at the 3 month examination. The following complications were reported 6 months after LASIK: 0.8% (2/262) of the eyes had a corneal epithelial defect and 0.8% (2/262) had any epithelium in the interface. Mixed astigmatism: In the mixed astigmatism clinical study, two adverse events were reported. The first event involved a patient who postoperatively was subject to blunt trauma to the treat- ment eye 6 days after surgery. The patient was found to have an intact globe with no rupture, inflammation or any dislodgement of the flap. UCVA was decreased due to this event. The second event involved the treatment of an incorrect axis of astigmatism. The axis was treated at 60 degrees instead of 160 degrees. The following complications were reported 6 months after LASIK: 1.8% (2/111) of the eyes had ghosting or double images in the operative eye. Wavefront-guided myopia: No adverse events occurred during the postoperative period of the wavefront-guided LASIK procedures. In the Control Cohort (traditional LASIK treatment) one subject undergoing traditional LASIK had the axis of astigmatism programmed as 115 degrees instead of the actual 155 degree axis. This led to cylinder in the left eye. The following complications were reported 6 months after wavefront-guided LASIK in the Study Cohort: 1.2% (2/166) of the eyes had a corneal epithelial defect; 1.2% (2/166) had foreign body sensation; and 0.6% (1/166) had pain. No complications were reported in the Control Cohort. New technologies enhancing patient outcomes

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