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6 • have recurrent corneal erosion; • have advanced glaucoma; or • have uncontrolled diabetes. Warnings: The WaveLight Excimer Laser Systems are not recommended for use with patients who have: • systemic diseases likely to affect wound heal- ing, 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; • a history of glaucoma; • an unreliable preoperative wavefront exami- nation that precludes wavefront-guided treat- ment; or • a poor quality preoperative topography map that precludes topography-guided LASIK 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 proce- dure must be validated by the user. Inaccurate or unreliable data from the wavefront examina- tion will lead to an inaccurate treatment. Topography-guided LASIK requires preop- erative topography maps of sufficient quality to use for planning a topography-guided LASIK treatment. Poor quality topography maps may affect the accuracy of the topography-guided LASIK treatment and may result in poor vision after topography-guided LASIK. 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 medications 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 compro- mising 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 wave- front 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 compli- cations, adverse events, and levels of effective- ness may have been determined for this population. Pupil sizes should be evaluated under mesopic illumination conditions. Effects of treat- ment 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 postoper- atively 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 sec- ond 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. Important product information 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 systems for use in laser-assisted in situ keratomileusis (LASIK) treatments for: • the reduction or elimination of myopia of up to –12.00 D and up to 6.00 D of astigmatism at the spectacle plane; • the reduction or elimination of hyperopia up to +6.00 D with and without astigmatic refrac- tive errors up to 5.00 D at the spectacle plane, with a maximum manifest refraction spherical equivalent of +6.00 D; • the reduction or elimination of naturally occurring mixed astigmatism of up to 6.00 D at the spectacle plane; and • the wavefront-guided reduction or elimination of myopia of up to –7.00 D and up to 3.00 D of astigmatism at the spectacle plane. In addition, FDA has approved the WaveLight ALLEGRETTO WAVE Eye-Q Excimer Laser System, when used with the WaveLight ALLEGRO Topolyzer and topography-guided treatment planning software for topography- guided LASIK treatments for the reduction or elimination of up to –9.00 D of myopia, or for the reduction or elimination of myopia with astigma- tism, with up to –8.00 D of myopia and up to 3.00 D of astigmatism. 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; • are taking isotretinoin (Accutane*) and/or amiodarone hydrochloride (Cordarone*); • have severe dry eye; • have corneas too thin for LASIK; WaveLight Excimer Laser Systems

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