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EW San Diego 2015 8 Pupil sizes should be evaluated under mesopic illumination conditions. Effects of treatment on vision under poor illu- mination 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, mis- placed, or misaligned flap reported at the 1 month examination. The following complications were report- ed 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 exam- ination. The following complications were report- ed 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 astig- matism clinical study, two adverse events were reported. The first event involved a patient who postoperatively was subject to blunt trauma to the treatment 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 astigma- tism. The axis was treated at 60 degrees instead of 160 degrees. The following complications were report- ed 6 months after LASIK: 1.8% (2/111) of the eyes had ghosting or double images in the operative eye. Wavefront-guided myopia: The wavefront-guided myopia clinical study included 374 eyes treated; 188 with wavefront-guided LASIK (Study Cohort) and 186 with Wavefront Optimized ® LASIK (Control Cohort). No adverse events occurred during the postoperative period of the wavefront-guided LASIK procedures. In the Control Cohort, 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 re- ported 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. Topography-guided myopia: There were six adverse events reported in the topog- raphy-guided myopia study. Four of the eyes experienced transient or temporary decreases in vision prior to the final 12 month follow-up visit, all of which were resolved by the final follow-up visit. One subject suffered from decreased vision in the treated eye, following blunt force trauma 4 days after surgery. One subject experienced retinal detachment, which was concluded to be unrelated to the surgical procedure. Clinical data Myopia: The myopia clinical study included 901 eyes treated, of which 813 of 866 eligible eyes were followed for 12 months. Accountability at 3 months was 93.8%, at 6 months was 91.9%, and at 12 months was 93.9%. Of the 782 eyes that were eligible for the uncorrected visual acuity (UCVA) analysis of effec- tiveness at the 6-month stability time point, 98.3% were corrected to 20/40 or better, and 87.7% were corrected to 20/20 or better. Subjects who responded to a patient satisfaction questionnaire before and after LASIK reported the fol- lowing visual symptoms at a "moderate" or "severe" level at least 1% higher at 3 months post-treatment than at baseline: visual fluctuations (28.6% vs. 12.8% at baseline). Long-term risks of LASIK for myopia with and without astigmatism have not been studied beyond 12 months. Hyperopia: The hyperopia clinical study included 290 eyes treated, of which 100 of 290 eligible eyes were followed for 12 months. Accountability at 3 months was 95.2%, at 6 months was 93.9%, and at 12 months was 69.9%. Of the 212 eyes that were eligible for the UCVA analysis of ef- fectiveness at the 6-month stability time point, 95.3% were corrected to 20/40 or better, and 69.4% were corrected to 20/20 or better. Subjects who responded to a patient satisfaction questionnaire be- fore and after LASIK reported the follow- ing visual symptoms as "much worse" at 6 months post-treatment: halos (6.4%); visual fluctuations (6.1%); light sensitivi- ty (4.9%); night driving glare (4.2%); and glare from bright lights (3.0%). Long-term risks of LASIK for hyperopia with and without astigmatism have not been studied beyond 12 months. Mixed astigmatism: The mixed astig- matism clinical study included 162 eyes treated, of which 111 were eligible to be followed for 6 months. Accountability at 1 month was 99.4%, at 3 months was 96.0%, and at 6 months was 100.0%. Of the 142 eyes that were eligible for the UCVA analysis of effectiveness at the 6-month stability time point, 97.3% achieved acuity of 20/40 or better, and 69.4% achieved acuity of 20/20 or better. Subjects who responded to a patient satisfaction questionnaire before and after LASIK reported the following visual symptoms at a "moderate" or "severe" level at least 1% higher at 3 months post-treatment than at baseline: sensitivi- ty to light (52.9% vs. 43.3% at baseline); visual fluctuations (43.0% vs. 32.1% at baseline); and halos (42.3% vs. 37.0% at baseline). Long-term risks of LASIK for mixed astig- matism have not been studied beyond 6 months. Wavefront-guided myopia: The wavefront-guided myopia clinical study included 374 eyes treated; 188 with wavefront-guided LASIK (Study Cohort) and 186 with Wavefront Optimized ® LASIK (Control Cohort). 166 of the Study Cohort and 166 of the Control Cohort were eligible to be followed at 6 months. In the Study Cohort, accountability at 1 month was 96.8%, at 3 months was 96.8%, and at 6 months was 93.3%. In the Control Cohort, accountability at 1 month was 94.6%, at 3 months was 94.6%, and at 6 months was 92.2%. Of the 166 eyes in the Study Cohort that were eligible for the UCVA analysis of ef- fectiveness at the 6-month stability time point, 99.4% were corrected to 20/40 or better, and 93.4% were corrected to 20/20 or better. Of the 166 eyes in the Control Cohort eligible for the UCVA analysis of effectiveness at the 6-month stability time point, 99.4% were correct- ed to 20/40 or better, and 92.8% were corrected to 20/20. In the Study Cohort, subjects who responded to a patient satisfaction questionnaire before and after LASIK reported the following visual symptoms at a "moderate" or "severe" level at least 1% higher at 3 months post-treatment than at baseline: light sensitivity (47.8% vs. 37.2% at baseline) and visual fluctu- ations (20.0% vs. 13.8% at baseline). In the Control Cohort, the following visual symptoms were reported at a "moderate" or "severe" level at least 1% higher at 3 months post-treatment than at baseline: halos (45.4% vs. 36.6% at baseline) and visual fluctuations (21.9% vs. 18.3% at baseline). Long-term risks of wavefront-guided LASIK for myopia with and without astigmatism have not been studied beyond 6 months. Topography-guided myopia: The topography-guided myopia clinical study included 249 eyes treated, of which 230 eyes were followed for 12 months. Ac- countability at 3 months was 99.2%, at 6 months was 98.0%, and at 12 months was 92.4%. Of the 247 eyes that were eligible for the UCVA analysis at the 3-month stability time point, 99.2% were corrected to 20/40 or better, and 92.7% were corrected to 20/20 or better. Sub- jects who responded to a patient satisfac- tion questionnaire before and after LASIK reported the following visual symptoms as "marked" or "severe" at an incidence greater than 5% at 1 month after surgery: dryness (7% vs. 4% at baseline) and light sensitivity (7% vs. 5% at baseline). Visual symptoms continued to improve with time, and none of the visual symptoms were rated as being "marked" or "severe" with an incidence of at least 5% at 3 months or later after surgery. Long-term risks of topography-guided LASIK for myopia with and without astigmatism have not been studied beyond 12 months. Information for patients: Prior to undergoing LASIK surgery with a WaveLight ® Excimer Laser System, pro- spective patients must receive a copy of the relevant Patient Information Booklet, and must be informed of the alternatives for correcting their vision, including (but not limited to) eyeglasses, contact lenses, photorefractive keratectomy, and other refractive surgeries. Attention: Please refer to a current WaveLight ® Excimer Laser System Pro- cedure Manual for a complete listing of the indications, complications, warnings, precautions, and side effects. *Trademarks are property of their respective owners. ALL13202BS Verion ® Image Guided System Verion ® Reference Unit and Verion ® Digital Marker Caution: Federal (USA) law restricts this device to sale by, or on the order of, a physician. Intended uses: The Verion ® Reference Unit is a preoperative measurement device that captures and utilizes a high-resolution reference image of a patient's eye. In addition, the Verion ® Reference Unit provides preoperative surgical planning functions to assist the surgeon with planning cataract surgical procedures. The Verion ® Reference Unit also supports the export of the reference image, preoperative measurement data, and surgical plans for use with the Veri- on ® Digital Marker and other compatible devices through the use of a USB memo- ry stick. The Verion ® Digital Marker links to compatible surgical microscopes to display concurrently the reference and microscope images, allowing the surgeon to account for lateral and rotational eye movements. In addition, details from the Verion ® Reference Unit surgical plan can be overlaid on a computer screen or the physician's microscope view. Contraindications: The following condi- tions may affect the accuracy of surgical plans prepared with the Verion ® Refer- ence Unit: a pseudophakic eye, eye fix- ation problems, a non-intact cornea, or an irregular cornea. In addition, patients should refrain from wearing contact lenses during the reference measurement as this may interfere with the accuracy of the measurements. The following condi- tions may affect the proper functioning of the Verion ® Digital Marker: changes in a patient's eye between preoperative measurement and surgery, an irregular elliptic limbus (e.g., due to eye fixation during surgery, and bleeding or bloated conjunctiva due to anesthesia). In addi- tion, the use of eye drops that constrict sclera vessels before or during surgery should be avoided. Warnings: Only properly trained personnel should operate the Verion ® Reference Unit and Verion ® Digital Marker. Use only the provided medical power supplies and data communication cable. Power supplies for the Verion ® Reference Unit and the Verion ® Digital Marker must be uninterruptible. Do not use these devices in combination with an extension cord. Do not cover any of the component devices while turned on. The Verion ® Reference Unit uses infrared light. Unless necessary, medical person- nel and patients should avoid direct eye exposure to the emitted or reflected beam. Precautions: To ensure the accuracy of Verion ® Reference Unit measurements, device calibration and the reference measurement should be conducted in dimmed ambient light conditions. Only use the Verion ® Digital Marker in conjunction with compatible surgical microscopes. Attention: Refer to the user manuals for the Verion ® Reference Unit and the Verion ® Digital Marker for a complete de- scription of proper use and maintenance of these devices, as well as a complete list of contraindications, warnings, and precautions. MIX1538JS-B

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