1. Physician Certification for CustomVue ™ Presbyopic Ablations

2. CustomVue ™ Presbyopic Ablations Presbyopic corrections are enabled only in combination with CustomVue hyperopic corrections with or without astigmatism and Iris Registration Presbyopic corrections are enabled only in combination with CustomVue hyperopic corrections with or without astigmatism and Iris Registration

3. CustomVue ™ Presbyopic Ablations Recommended Treatment Parameters: Recommended Treatment Parameters: –Maximum WaveScan ™ sphere +4.50D –Maximum WaveScan cylinder +1.50D –Maximum SE+4.50D

4. CustomVue ™ Presbyopic Ablations Presbyopic correction creates a multifocal ablation that provides for a pupil-based central corneal steepening of approximately 1.0 D Presbyopic correction creates a multifocal ablation that provides for a pupil-based central corneal steepening of approximately 1.0 D This central corneal steepening has a variable effect on the patient’s reading vision This central corneal steepening has a variable effect on the patient’s reading vision

5. CustomVue ™ Presbyopic Ablations Patented VISX ™ multifocal ablation profile VSS ™ and VRR ™ ablation technology used to create subtle ablation shape change to subject’s wavefront map Central zone steepened to provide near vision Peripheral zone targeted for distance vision

6. CustomVue ™ Presbyopic Ablations Patented VISX ™ multifocal ablation profile The combination of the pupil-size dependent central zone, the peripheral zone, and the LASIK flap produces an aspheric curve that expands the depth of focus

7. CustomVue ™ Presbyopic Ablations Pre-operative Evaluation CustomVue ™ Presbyopic Ablations Pre-operative Evaluation

8. CustomVue ™ Presbyopic Ablations Pre-operative Examination WaveScan ™ System WaveScan ™ System –WaveScan exams with 6.0 mm pupils are preferred for treatments The minimum pupil size of the wavefront- measurement must be > 5.0 mm to calculate a CustomVue treatment The minimum pupil size of the wavefront- measurement must be > 5.0 mm to calculate a CustomVue treatment Measurements with a pupil size < 5.0 mm will be unavailable for selection Measurements with a pupil size < 5.0 mm will be unavailable for selection Wavefront diameter captures of greater than 7.0 mm will not allow presbyopic shape creation or treatment Wavefront diameter captures of greater than 7.0 mm will not allow presbyopic shape creation or treatment

9. CustomVue ™ Presbyopic Ablations WaveScan ™ Acquisition Users are warned to carefully monitor the wavefront diameter when using the presbyopia software WaveScan measurements for presbyopia should be done with a dark-adapted physiologic pupil Pharmacologic pupil manipulation is specifically NOT recommended as the treatment is calculated as a percentage of physiologic pupil size

10. CustomVue ™ Presbyopic Ablations Pre-operative Examination Contact Lens Use: Contact Lens Use: –Soft contact lenses - discontinue lens wear at least two weeks prior to examination and treatment –Hard (PMMA) or RGP lenses - discontinue lens wear at least three weeks prior to examination and treatment with stable keratometry and refraction 3 central keratometry readings and MR taken at 1 week intervals. The last two readings must not differ by > 0.5D 3 central keratometry readings and MR taken at 1 week intervals. The last two readings must not differ by > 0.5D –The WaveScan ™ measurements should be stable prior to the treatment

11. CustomVue ™ Presbyopic Ablations Pre-operative Examination Visual Acuity Visual Acuity –UCVA, BSCVA Refraction Refraction –Manifest Refraction – Hyperopia – Pushed plus technique Hyperopia – Pushed plus technique Astigmatism - Jackson Cross Cylinder - maximize magnitude of cylinder Astigmatism - Jackson Cross Cylinder - maximize magnitude of cylinder

12. CustomVue ™ Presbyopic Ablations Pre-operative Examination When comparing Manifest Refraction to WaveScan ™ Refraction use the 4 mm diameter WaveScan data When comparing Manifest Refraction to WaveScan ™ Refraction use the 4 mm diameter WaveScan data –This most closely approximates the MR

13. CustomVue ™ Presbyopic Ablations Pre-operative Examination Refraction Techniques Cycloplegic Refraction (1% cyclopentolate) Cycloplegic Refraction (1% cyclopentolate) True cycloplegia eliminates accommodation and allows appropriate refractive evaluation of: True cycloplegia eliminates accommodation and allows appropriate refractive evaluation of: –Latent hyperopia Critical in all Hyperopes Critical in all Hyperopes

14. CustomVue ™ Presbyopic Ablations Pre-operative Examination The anticipated post-operative keratometry value in any meridian must be < 50 D The anticipated post-operative keratometry value in any meridian must be < 50 D To calculate the anticipated postoperative K’s a dd the Mean Pre-Op Keratometry to the Pre-Op MRSE – –Use Manual or Auto K’s – –Do not use “Sim K’s”

15. CustomVue ™ Presbyopic Ablations Pre-operative Examination Keratometry Keratometry –K1 is the flat K –K2 is the steep K –K2 Axis is the axis of the steep K Pupillary Exam Pupillary Exam –Bright and dim illumination measurement Corneal Topography - necessary in all patients Corneal Topography - necessary in all patients –R/O Keratoconus or any other abnormality –R/O CL related abnormalities –Verify post-operative results

16. CustomVue ™ Presbyopic Ablations Pre-operative Examination Slit Lamp Exam Slit Lamp Exam Tonometry Tonometry Pachymetry Pachymetry –Ultrasonic pachymetry required for LASIK Dilated Media and Fundus Exam Dilated Media and Fundus Exam

17. CustomVue ™ Presbyopic Ablations Surgical Planning Surgical Technique CustomVue ™ Presbyopic Ablations Surgical Planning Surgical Technique

18. CustomVue™ Presbyopic Ablations Treatment Design Screen You must select LASIK or Surface PRK in the TREATMENT TYPE field The Presbyopia ablation is different in LASIK vs. Surface PRK in LASIK vs. Surface PRK

19. CustomVue ™ Presbyopic Ablations Treatment Design Screen Check the ENABLE box to enable a presbyopic correction

20. CustomVue ™ Presbyopic Ablations Environmental Conditions CustomVue Presbyopic procedures are done with Variable Spot Scanning (VSS ™ ) and Variable Repetition Rate (VRR ™ ) CustomVue Presbyopic procedures are done with Variable Spot Scanning (VSS ™ ) and Variable Repetition Rate (VRR ™ ) –Even though the repetition rate varies from 6 to 20 Hz these treatments tend to be longer in duration than myopic treatments It is important to pay careful attention to environmental conditions It is important to pay careful attention to environmental conditions

21. CustomVue ™ Presbyopic Ablations Environmental Conditions Control of environmental conditions during CustomVue treatments is important. In previous U.S. FDA Multi- Center Clinical Trials, the room conditions were: Control of environmental conditions during CustomVue treatments is important. In previous U.S. FDA Multi- Center Clinical Trials, the room conditions were: –Temperature ranged from 68ºF to 72ºF (20ºC to 22.2ºC) –Relative humidity ranged from 40% to 45% –Treatments performed at >75º were associated with less accurate outcomes Stability of temperature and humidity is important Stability of temperature and humidity is important

22. CustomVue ™ Presbyopic Ablations CustomVue ™ Presbyopic Ablations Iris Registration Iris pattern is unique to each eye Iris pattern is unique to each eye IR aligns the preoperative WaveScan ™ System and intra-operative STAR S4 IR ™ System iris images IR aligns the preoperative WaveScan ™ System and intra-operative STAR S4 IR ™ System iris images

23. CustomVue ™ Presbyopic Ablations CustomVue ™ Presbyopic Ablations Iris Registration Diagnostic measurement (mesopic) LVC Treatment (photopic) As the pupil changes size, its centroid may not remain stationary, relative to the outer iris boundary Outer Iris Boundary For International Use Only

24. CustomVue ™ Presbyopic Ablations CustomVue ™ Presbyopic Ablations Iris Registration (IR) IR is a critically important component of Presbyopia treatments IR is a critically important component of Presbyopia treatments –Proper registration of wavefront-guided ablation –Proper placement of the pupil-size dependent central zone relative to the pupil centroid

25. CustomVue ™ Hyperopia Surgical Technique Do not use a Chayet drain or similar device Do not use a Chayet drain or similar device Create and lift flap Create and lift flap Align limbal marks with reticle hash marks Align limbal marks with reticle hash marks Dry exposed stromal bed if there is fluid accumulation Dry exposed stromal bed if there is fluid accumulation Perform ablation Perform ablation Interrupt ablation only if there is fluid accumulation Interrupt ablation only if there is fluid accumulation Replace flap Replace flap

26. VISX ™ Hyperopic Presbyopia Completion of Certification Acknowledgement of Understanding: By checking the box below, I acknowledge I have read and understood this material