Contains Nonbinding Recommendations 
 
Draft  Not for Implementation 
 
Laser-Assisted In Situ Keratomileusis 
(LASIK) Lasers - Patient Labeling 
Recommendations 
______________________________________________________________________________ 
Draft Guidance for Industry and 
Food and Drug Administration Staff 
 
DRAFT GUIDANCE 
 
This draft guidance document is being distributed for comment purposes 
only. 
 
Document issued on July 28, 2022. 
 
You should submit comments and suggestions regarding this draft document within 120 days of 
publication in the Federal Register of the notice announcing the availability of the draft 
guidance. Submit electronic comments to https://www.regulations.gov. Submit written 
comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Identify all comments with the docket number 
listed in the notice of availability that publishes in the Federal Register. 
 
For questions about this document, contact the OHT1: Office of Ophthalmic, Anesthesia, 
Respiratory, ENT and Dental Devices/DHT1A: Division of Ophthalmic Devices at (301) 796-
5620.  
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Devices and Radiological Health 
   Contains Nonbinding Recommendations 
 
Draft  Not for Implementation 
 
Preface 
 
Additional Copies 
 
Additional copies are available from the Internet. You may also send an email request to CDRH-
Guidance@fda.hhs.gov to receive a copy of the guidance. Please include the document number 
16053 and complete title of the guidance in the request.  Contains Nonbinding Recommendations 
 
Draft  Not for Implementation 
 
Table of Contents
 
I.  Introduction ............................................................................................................................... 1 
II.  Background ............................................................................................................................... 2 
III. Scope   ...................................................................................................................................... 3 
IV. Patient Labeling Components ................................................................................................... 4 
A.  General Considerations .................................................................................................... 4 
B.  Suggested Format and Content of Patient Labeling ......................................................... 5 
  Description of the Eye and the Surgery ........................................................................ 6 
  Purpose of the Device (Indications for Use) ................................................................ 6 
  What are the Benefits? .................................................................................................. 6 
  What are the Alternatives? ........................................................................................... 6 
  Contraindications, Warnings, and Precautions ............................................................. 6 
  What are the Risks? .................................................................................................... 14 
  What to Expect Before, During, and After Surgery ................................................... 19 
  Clinical Study Information ......................................................................................... 20 
  Contact Information .................................................................................................... 20 
  Patient Decision Considerations ............................................................................. 20 
Appendix A: Patient Decision Checklist Example ....................................................................... 22 
 
  Contains Nonbinding Recommendations 
 
Draft  Not for Implementation 
 
Laser-Assisted In Situ Keratomileusis 
1 
(LASIK) Lasers - Patient Labeling 
2 
Recommendations 
3 
4  ______________________________________________________________________________ 
Draft Guidance for Industry and 
5 
Food and Drug Administration Staff 
6 
7   
8  This draft guidance, when finalized, will represent the current thinking of the Food and Drug 
9  Administration (FDA or we) on this topic. It does not establish any rights for any person and 
10  is not binding on FDA or the public. You can use an alternative approach if it satisfies the 
11  requirements of the applicable statutes and regulations. To discuss an alternative approach, 
12  contact the FDA staff or Office responsible for this guidance as listed on the title page.  
13  I.  Introduction 
14  This draft guidance recommends content and formatting for patient labeling information for 
15  laser-assisted in situ keratomileusis (LASIK) devices. FDA is issuing this guidance to help 
16  ensure that both physicians can share and patients can understand information on the benefits and 
17  risks of these devices. The recommendations are being made based on concerns that some 
18  patients are not receiving and/or understanding information regarding the benefits and risks of 
19  LASIK devices. These labeling recommendations are intended to enhance, but not replace, the 
20  physician-patient discussion of the benefits and risks of LASIK devices that uniquely pertain to 
21  individual patients. 
22   
23  For the current edition of the FDA-recognized consensus standard(s) referenced in this 
24  document, see the FDA Recognized Consensus Standards Database.1 For more information 
25  regarding use of consensus standards in regulatory submissions, please refer to the FDA 
26  guidance titled Appropriate Use of Voluntary Consensus Standards in Premarket Submissions 
27  for Medical Devices.2 
28   
29  The contents of this document do not have the force and effect of law and are not meant to bind 
30  the public in any way, unless specifically incorporated into a contract. This document is intended 
31  only to provide clarity to the public regarding existing requirements under the law. FDA 
32  guidance documents, including this guidance, should be viewed only as recommendations, unless 
 
1 Available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm.  
2 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-
voluntary-consensus-standards-premarket-submissions-medical-devices. 
1 
  Contains Nonbinding Recommendations 
 
Draft  Not for Implementation 
 
33  specific regulatory or statutory requirements are cited. The use of the word should in Agency 
34  guidance means that something is suggested or recommended, but not required. 
35   
36  II.  Background 
37  LASIK is an outpatient refractive surgery procedure used to help correct refractive errors to 
38  reduce dependency on eyeglasses. Refractive errors arise when the shape of the cornea (the clear, 
39  round dome at the front of the eye) and the eye are not perfect and the image on the retina is out-
40  of-focus (blurred) or distorted. These imperfections in the focusing power of the eye are called 
41  refractive errors, such as myopia (nearsightedness), hyperopia (farsightedness), and 
42  astigmatism. In a LASIK procedure, a laser is used to reshape the cornea to improve the way the 
43  eye focuses light rays onto the retina at the back of the eye. LASIK is currently one of the most 
44  commonly performed elective procedures in the world, as well as the most popular form of 
45  refractive surgery that patients choose to correct common vision problems such as 
46  nearsightedness, farsightedness, and astigmatism.3  
47   
48  On April 25, 2008, FDA convened its Ophthalmic Devices Panel of the Medical Devices 
49  Advisory Committee to discuss recommendations for modifications to patient labeling of 
50  excimer lasers for LASIK as well as other LASIK-related activities. During this meeting, patient 
51  advocacy groups also highlighted the importance of clearly communicating the risks of LASIK.4  
52  Since the time of the LASIK Advisory Committee meeting, FDA has continued to gather new 
53  information pertaining to risks associated with LASIK, including dry eye, pain and discomfort, 
54  and visual symptoms. Clinical and scientific knowledge about these events and symptoms has 
55  increased since the time of the last advisory committee meeting. FDA has diligently collaborated 
56  with external experts on research efforts, including focus groups, to better characterize risks to 
57  ensure that the recommended labeling discussed in this guidance addresses the concerns 
58  uncovered in this collaboration and that risk information is communicated in an understandable 
59  format.  
60  As one example of these efforts, in October 2009, the FDA, the National Eye Institute (NEI), and 
61  the Department of Defense (DoD) launched the LASIK Quality of Life Collaboration Project 
62  (LQOLCP) to better understand the potential risk of severe problems that can result from 
63  LASIK.5 At the time the collaboration partners developed the project, there was a limited amount 
64  of valid scientific data on certain patient-reported outcomes (PROs) related to LASIK. A PRO is 
65  a report of how patients feel and function reported by the patient, not the health care provider. 
66  The Patient-Reported Outcomes with LASIK (PROWL) studies in the LQOLCP assessed visual 
 
3 Vitale, S., et al., Costs of refractive correction of distance vision impairment in the United States, 1999-2002. 
Ophthalmology, 2006. 113(12): p. 2163-70. 
4 One Hundred and Tenth Meeting of the Ophthalmic Devices Panel of the Medical Devices Advisory Committee, 
Laser-assisted in situ keratomileusis (LASIK) Post Market Experience, April 25, 2008, 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfAdvisory/details.cfm?mtg=695. 
5 For additional information on the LASIK Quality of Life Collaboration Project, see https://www.fda.gov/medical-
devices/lasik/lasik-quality-life-collaboration-project.   
2 
  Contains Nonbinding Recommendations 
 
Draft  Not for Implementation 
 
67  symptoms before and after LASIK surgery to identify changes over time. There were multiple 
68  phases to the PROWL studies, the final of which was completed in 2014. Although not the focus 
69  of the studies, the information gathered regarding risks and patient experiences were informative 
70  to these guidance recommendations.  
71  In addition, FDA is aware that patients may not be receiving information in a format that allows 
72  them to make a well-informed decision about whether to have LASIK. The recommendations in 
73  this guidance are being made to help ensure that patients are informed of the significant risks 
74  associated with LASIK prior to choosing this type of surgery and are informed by the latest 
75  information about these devices. 
76   
77  FDA is issuing this draft guidance to reflect the Agencys current thinking on labeling specific to 
78  LASIK devices, and to enable the public to comment on these recommendations, including the 
79  recommended language for inclusion in patient labeling and a patient decision checklist, as 
80  described below. FDA believes this information, in conjunction with physician-patient 
81  discussion, will help to ensure that a patient receives relevant information on and understands the 
82  benefits and risks associated with LASIK so that the patient can make an informed decision as to 
83  whether the procedure is the right choice for him/her prior to undergoing the procedure. In 
84  addition, the Agency will continue to monitor information about potential safety risks and take 
85  steps to ensure they are being adequately conveyed to and understood by physicians and patients. 
86   
87  III.  Scope 
88  This draft guidance recommends content and formatting of patient labeling information for 
89  LASIK devices, including a patient decision checklist. This draft guidance applies to all 
90  refractive lasers with LASIK indications for use (FDA product code LZS).6  
91   
92  LASIK devices are prescription devices and are exempt from having adequate directions for lay 
93  use required under section 502(f)(1) of the FD&C Act (21 U.S.C.  352(f)(1)) as long as the 
94  conditions in 21 CFR 801.109 are met. FDA believes it is important for patients considering 
95  LASIK surgery to have the information they need for a balanced discussion of benefits and risks 
96  with their physicians. It is also important for physicians to know how to educate their patients 
97  about risks that might arise as a result of LASIK surgery. As such, FDA believes it is important 
98  for manufacturers to include information for both physicians and also for patients about the risks 
99  of the device  including but not limited to information that can inform the patient of the possible 
100  risks to health associated with LASIK surgery. This information should appear in a format that a 
101  physician can easily convey directly to the patient. To help ensure that both physicians and 
102  patients receive and have this information, patient labeling, including a patient decision 
103  checklist, should be provided by manufacturers and given to physicians and patients prior to a 
104  LASIK procedure, and should include considerations related to procedural information, 
 
6 Other ophthalmic laser devices, such as those indicated for photorefractive keratectomy under FDA product code 
LZS and those covered by FDA product code OTL, are not contemplated by and therefore outside the scope of this 
draft guidance. 
3 
  Contains Nonbinding Recommendations 
 
Draft  Not for Implementation 
 
105  candidate considerations, benefits/alternatives, contraindications, warnings and precautions, and 
106  specific health risk information.  
107   
108  Accurate product labeling and effective communication of that labeling is important to make 
109  device users and patients aware of the risks associated with LASIK devices. Moreover, a device 
110  shall be deemed misbranded if, among other things: its labeling is false or misleading; its 
111  labeling does not contain adequate warnings; or any information required to be in the labeling is 
112  not prominently placed with such conspicuousness and in such terms to render it likely to be read 
113  and understood by the ordinary individual under customary conditions of purchase and use (see 
114  sections 502(a), 201(n), 502(c), and 502(f)(2) of the Federal Food, Drug, and Cosmetic Act 
115  (FD&C Act)).7 FDA intends to work with manufacturers of new LASIK devices through the 
116  premarket approval application (PMA) process, and manufacturers of currently marketed LASIK 
117  devices through the PMA supplement process, to integrate these important labeling 
118  recommendations. Since it is anticipated that such a change will enhance the safe use of the 
119  device, updated labeling may qualify for a submission as a Special PMA Supplement -- Changes 
120  Being Effected.8  
121   
122  This guidance should be used as a complement to FDAs, Guidance on Medical Device Patient 
123  Labeling (which describes FDAs current thinking on making medical device patient labeling 
124  understandable to and usable by patients), existing regulations, and other relevant guidance 
125  documents containing additional labeling recommendations.9 
126   
127  IV.  Patient Labeling Components 
128  A. General Considerations 
129  The patient labeling should be directed to potential candidates for LASIK and should address the 
130  following questions: 
131   
132    What is LASIK surgery? 
133    What is the specific LASIK device used for the patients procedure?  
134    What are the approved indications for use specific to the LASIK device? 
135    What makes someone a poor candidate for LASIK? 
136    What factors should a patient consider in deciding whether LASIK is appropriate for 
137  him or her? 
138    What are the benefits, risks, and alternatives to LASIK? 
 
7 Under section 301(a) of the FD&C Act, it is a prohibited act to introduce or deliver for introduction into interstate 
commerce any device that is misbranded. 
8 21 CFR 814.39(d). For additional information, please also see Modifications to Devices Subject to Premarket 
Approval (PMA)  The PMA Supplement Decision Making Process (https://www.fda.gov/regulatory-
information/search-fda-guidance-documents/modifications-devices-subject-premarket-approval-pma-pma-
supplement-decision-making-process).  
9 See Guidance on Medical Device Patient Labeling (https://www.fda.gov/regulatory-information/search-fda-
guidance-documents/guidance-medical-device-patient-labeling). 
4 
  Contains Nonbinding Recommendations 
 
Draft  Not for Implementation 
 
139    What should a patient expect before, during, and after LASIK?  
140   
141  Patient labeling should be written in simple, lay language that can be read and understood by 
142  prospective patients who may not be familiar with LASIK and its related terminology. Clearly 
143  labeled, relevant graphics may be used to improve patient understanding. 
144   
145  Even with technically accurate lay language, poorly designed text can still be confusing and 
146  misleading. Before completing the patient labeling, the text should be tested with representative 
147  users in a controlled test situation to determine whether they comprehend the information 
148  sufficiently to understand the risks, make appropriate choices, and know what to expect from 
149  treatment with the device. During the development of the patient labeling, manufacturers should 
150  identify the critical information that the labeling needs to convey, and test it iteratively to 
151  determine whether the users comprehend that information correctly, e.g., by having users recite 
152  what they have learned. Manufacturers should also work to alter the method(s) of delivering this 
153  information, as appropriate, until users demonstrate adequate comprehension. Testing in these 
154  iterative phases may not necessitate large numbers of subjects.10  
155   
156  When translating the health care provider labeling into lay language, manufacturers should 
157  ensure that there are no changes to the intent of the indications, contraindications, warnings and 
158  precautions, or other parts of the health care provider labeling. The lay translation should provide 
159  a balanced presentation of the benefits and risks of the device for the indications for use. It 
160  should not introduce new information or statements about product performance that are not in the 
161  health care provider labeling, but should instead be a reflection of the information provided in 
162  the health care provider labeling geared towards a lay audience. 
163  B. Suggested Format and Content of Patient Labeling 
164  FDA recommends that patient labeling also contains the information in the sections outlined in 
165  the FDAs Guidance on Medical Device Patient Labeling.11 As recommended above, the 
166  content should be written in a way that informs patients of the benefits, risks, and alternatives to 
167  the specific indication for use of the device in simple, lay language they can understand. The 
168  sequence of the sections suggested in the guidance may be adapted as appropriate for a specific 
169  device and indication, but should enable the patient to easily find and understand information 
170  that answers the questions identified above. This section also includes informational content and 
171  format suggestions for inclusion in LASIK patient labeling.  
 
10 An iterative approach to usability testing is further described as part of the usability engineering process in the 
currently FDA-recognized version of IEC 62366-1: Medical devices  Part 1: Application of usability engineering 
to medical devices. 
11 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-medical-
device-patient-labeling.  
 
5 
  Contains Nonbinding Recommendations 
 
Draft  Not for Implementation 
 
172    Description of the Eye and the Surgery  
173  a.  How Your Eye Works 
174  For this part of the labeling, FDA recommends including a brief description of the optics of the 
175  eye and the causes of refractive errors with an emphasis upon the refractive role of the cornea. 
176  FDA recommends that manufacturers include appropriate, clearly labeled diagrams to illustrate 
177  the described concepts.   
178  b.  What Is LASIK and What Does the [XX] LASIK Laser Do? 
179  This part of the labeling should include a brief description of the steps of LASIK (with clearly 
180  labeled diagrams) and how the device is used to correct refractive errors consistent with the 
181  indications for use. If the device has special features, such as wavefront guidance, these could 
182  also be explained in this section.  
183   
184  FDA also recommends explaining what the device and LASIK cannot do, to help ensure that 
185  patients have realistic expectations of LASIK.  
186    Purpose of the Device (Indications for Use) 
187  For this part of the labeling, FDA recommends including a brief description of the FDA-
188  approved Indications for Use in lay terms, including the key characteristics that define the 
189  intended patient population, such as the following: 
190   
191    Range of the refractive error  
192    Age range 
193    Definition of pre-operative refractive stability 
194    What are the Benefits? 
195  This part of the labeling should include a description of the specific benefits patients should 
196  expect from the device in a balanced, factual, and non-promotional manner. FDA also 
197  recommends that the description include discussion of the limitations of surgery to try to prevent 
198  potential unrealistic expectations about the results of surgery. FDA recommends that you not 
199  present the specific results of PMA studies in this section because the results are provided in a 
200  separate clinical study section (see section III.B.(8)). 
201    What are the Alternatives? 
202  This part of the labeling should include an explanation that LASIK is an elective surgery, and 
203  discuss available alternatives for the correction of refractive error, both non-surgical and 
204  surgical, including their key risks and benefits. 
205    Contraindications, Warnings, and Precautions 
206  This part of the labeling should include a description of the contraindications, warnings, and 
207  precautions in the patient labeling. These should be the same as those listed in the health care 
208  provider labeling (except for those related to the operation of the device) and should be written in 
209  lay terms. 
6 
  Contains Nonbinding Recommendations 
 
Draft  Not for Implementation 
 
210   
211  FDA recognizes that proper patient selection is a key element in ensuring good outcomes from 
212  LASIK. Accordingly, FDA believes it is important that any included descriptions of 
213  contraindications, warnings, and precautions be presented in a way that enables patients 
214  considering LASIK to easily recognize, understand, and evaluate the characteristics and 
215  conditions that may affect their suitability as candidates for the surgery. For each 
216  contraindication, warning, and precaution, the patient labeling should include an explanation of 
217  why the condition may result in a particular problem. Because certain conditions appear in more 
218  than one of the subsections on contraindications, warnings, and precautions, FDA recommends 
219  that this information be summarized in table format, as shown in Table 1 below, as well as 
220  explained in the text of each subsection. Examples are provided in each of the subsections below. 
221   
222  The following is an example summary table and text for introducing it: 
223   
224  Table 1 is a quick reference that you can use to start a conversation with your doctor about 
225  whether LASIK is right for you. Mark those characteristics or conditions that you know 
226  apply to you and discuss them with your doctor, if you are considering LASIK. Ask your 
227  doctor whether any of the other characteristics or conditions apply to you, and, if so, how 
228  they may affect your risk of LASIK complications. Greater detail is provided below the table 
229  about these characteristics and conditions and what complications or side effects may arise if 
230  you have one of them and choose to have LASIK. 
231    
232  Table 1. Characteristics and Conditions Considered to Evaluate Suitability for LASIK (to be 
233  discussed with your doctor) 
234    When you should not have LASIK (Contraindications) 
235   When you should consider not having LASIK (Warnings) 
236   *  Other things that may increase your risk of LASIK complications (Precautions) 
237   
Characteristic/Condition  Check the Box if the Characteristic Applies to You 
Dry eyes     If you have severe dry eyes 
   If you have moderate or mild dry eyes 
Cornea not thick enough     If the clear front part of your eye is not thick 
enough 
Thinning of the cornea (see Image     If you have any condition that causes thinning 
1)  or bulging of the cornea, including: 
  Cone-shaped cornea (keratoconus)  
  Thinning of the bottom part of the cornea 
(pellucid marginal degeneration) 
  * If you have a family history of thinning of the 
cornea 
7 
  Contains Nonbinding Recommendations 
 
Draft  Not for Implementation 
 
Eye infection     If you have an active eye infection  
Eye inflammation     If you currently have an eye inflammation  
  * If you have a history of any eye disease (e.g., 
uveitis), abnormality, injury, or surgery 
Herpes eye infection      If you have had a recent eye infection or 
problems resulting from a past infection 
   If you have had a past eye infection 
Autoimmune or connective tissue     If you have an active autoimmune or 
disease (rheumatoid arthritis, lupus)  connective tissue disease 
   If you have an autoimmune or connective 
tissue disease that is controlled 
Glaucoma     If you have uncontrolled glaucoma (your eye 
pressure is too high even with treatment) 
   If you have controlled glaucoma 
  * If you have elevated eye pressure (ocular 
hypertension) or are being followed for possible 
glaucoma 
Diabetes     If you have uncontrolled diabetes (your blood 
sugar is not well controlled despite treatment)  
   If you have controlled diabetes 
Activities     If you participate in activities that could 
damage the LASIK flap, including contact 
sports (e.g., football) 
  * If you participate in activities that require 
good vision in poor lighting conditions to avoid 
a hazard (e.g., driving at night) 
Medications     If you take medications that have dry eyes 
as a side effect, such as: 
  Isotretinoin  
  Steroids 
  Medications that weaken the immune system 
(immunosuppressants)  
  * If you take any of the following medications:  
  Amiodarone hydrochloride  
  Sumatriptan  
8 
  Contains Nonbinding Recommendations 
 
Draft  Not for Implementation 
 
Repeated attacks of sharp eye pain     If you have a condition in which the outer 
due to epithelial basement  layer of corneal cells does not stick well to 
membrane dystrophy  other layers (epithelial basement membrane 
dystrophy)  
Weakened immune system     If you have a weakened immune system due 
to medications (such as steroids) or a medical 
condition (such as AIDS) 
Crossed eyes (strabismus)     If you have crossed eyes  
Decreased vision in one eye     If you have decreased vision in one eye 
Large pupils or very nearsighted    * If you have large pupils or are very 
nearsighted 
Allergies or eye rubbing    * If you have allergies or rub your eyes 
238   
239  If you are considering LASIK, make sure that you have been checked by your doctor for the 
240  characteristics and conditions above and let your doctor know if you have any of these 
241  characteristics or have ever experienced any of these conditions. 
242  a.  When You Should Not Have LASIK (Contraindications)  
243  This section should discuss conditions or situations in which the device should not be used 
244  because the known or reasonably foreseeable risk of using the device outweighs any reasonably 
245  foreseeable benefit. For example: 
246   
247  Please inform your doctor if you have ANY of the following conditions, which greatly 
248  increase the risk of harm from LASIK, including possible permanent loss of vision. Your 
249  doctor may determine, based on this information and/or your clinical examination, that you 
250  should NOT have LASIK: 
251   
252    Severe dry eye. LASIK can worsen this problem, even if successfully treated before 
253  LASIK, and increase your risk of infection and/or scarring. Symptoms of dry eye may 
254  include a scratchy or sandy feeling in the eye, stinging, burning, episodes of excessive 
255  tearing, a stringy discharge from the eye, pain, redness, eye fatigue, light sensitivity, 
256  and blurred vision. If you are not able to tolerate wearing contact lenses, this may be a 
257  sign that you have dry eyes. Make sure your LASIK doctor checks you for dry eyes 
258  before having LASIK. 
259   
260    Cornea not thick enough. Your cornea (the clear front part of the eye) must be thick 
261  enough to undergo LASIK without increasing the risk of causing an abnormal bulging 
262  forward of the cornea (ectasia), which could decrease your vision. Ask your LASIK 
263  doctor whether the thickness of your cornea puts you at greater risk for this 
264  complication.  
265   
9 
  Contains Nonbinding Recommendations 
 
Draft  Not for Implementation 
 
266    Thinning of the cornea. If you have a cone-shaped cornea (keratoconus; see Image 
267  1), thinning of the bottom part of the cornea along the edges (pellucid marginal 
268  degeneration), or any other condition that may cause a thinning or bulging of your 
269  cornea, LASIK can worsen these conditions and cause a permanent reduction in your 
270  vision. This may result in the need for additional surgery (such as a corneal 
271  transplant) after LASIK. Your LASIK doctor should map the shape of your cornea 
272  before LASIK to make sure you do not have any thinning. 
273   
274   
275   
276   
277  Image 1 Thinning of the cornea, or keratoconus12 
278   
279    Active eye infection or active inflammation. If you have an active infection or 
280  inflammation of the eye (such as keratitis, iritis, or uveitis), LASIK will likely make 
281  your condition worse, resulting in permanent eye damage. Let your LASIK doctor 
282  know if you are currently being treated, or if you have ever been treated, for such a 
283  condition.  
284   
285    Recent herpes eye infection or problems resulting from past infection. If you 
286  have had a herpes (simplex or zoster) eye infection within the past year or you have 
287  had corneal damage from prior herpes infections, you are at higher risk for further 
288  corneal damage after LASIK. Let your LASIK doctor know if you have ever had a 
289  herpes eye infection. 
290   
291    Active autoimmune or connective tissue disease. If you have an active connective 
292  tissue disease or autoimmune disease (such as rheumatoid arthritis and lupus) that can 
293  cause corneal melting, LASIK will increase your risk of severe damage to your 
294  cornea and vision loss. Let your LASIK doctor know about any medical conditions 
295  you have.  
296   
297    Uncontrolled glaucoma. If you have uncontrolled glaucoma, the increased eye 
298  pressure associated with cutting the LASIK flap puts you at greater risk for loss of 
299  vision. Let your LASIK doctor know if you have been diagnosed with glaucoma. 
300   
 
12 Image from http://www.cornea.org/Learning-Center/Conditions-Research-Areas/Keratoconus.aspx.  
10 
  Contains Nonbinding Recommendations 
 
Draft  Not for Implementation 
 
301    Uncontrolled diabetes. If your blood sugar is uncontrolled, your eyeglass 
302  prescription can fluctuate and your doctor will not be able to accurately determine 
303  what degree of LASIK treatment is appropriate. Uncontrolled diabetes can also 
304  negatively affect wound healing after LASIK. Let your LASIK doctor know if you 
305  have diabetes. 
306  b.  When You Should Consider Not Having LASIK (Warnings) 
307  This part of the labeling should discuss conditions under which there is reasonable evidence of 
308  an association of a serious harm with the use of the device and a persons suitability for the 
309  surgery should be carefully evaluated. This section should also provide information about the 
310  patient groups or conditions for which device safety and effectiveness has not been adequately 
311  studied, and for which use of the device would be expected to lead to adverse health outcomes or 
312  limited effectiveness, e.g., outside the approved refractive range. The following is one example 
313  of a set of warnings that follow the above recommendations: 
314   
315  Please inform your doctor if you have ANY of the following conditions that may result in a 
316  greater risk for poor outcomes or injury related to LASIK. You should discuss your level of 
317  risk with your doctor. You and your doctor should determine whether the benefits to you 
318  outweigh the risks based on the nature and severity of your condition. 
319   
320    Moderate or mild dry eyes. If you have dry eyes, LASIK can worsen dryness, 
321  discomfort and blurred vision. This may or may not get better. If you take certain 
322  medications, such as nasal decongestants, you are at greater risk of having dry eyes. If 
323  you have a condition that can cause dry eye, such as thyroid disease, Sjogrens syndrome, 
324  lupus, or rheumatoid arthritis, you are also at greater risk. Make sure your LASIK doctor 
325  checks you for dry eyes before having LASIK.   
326   
327    Past herpes eye infection. If you have any history of herpes (simplex or zoster) infection 
328  in your eyes, LASIK might reactivate the infection.  Let your LASIK doctor know if you 
329  have ever had an eye infection or eye inflammation.  
330   
331    Controlled glaucoma. If you have glaucoma, LASIK may make monitoring your eye 
332  pressure more difficult. You may also be at greater risk for damage to your vision 
333  associated with cutting the LASIK flap. The steroid drops used after the surgery may 
334  raise your eye pressure and cause glaucoma to worsen. Let your LASIK doctor know if 
335  you have been diagnosed with glaucoma.  
336   
337    Activities that could damage the LASIK flap. The flap is a tongue-shaped section of 
338  corneal tissue that is cut and lifted up during LASIK and which can wrinkle, move out of 
339  place, or break off even years after surgery. Participation in contact sports, like football 
340  or martial arts, increases your risk for dislocation, or even, loss of the flap. You should 
341  discuss your work activities and hobbies with your LASIK doctor prior to surgery to help 
342  determine whether LASIK is right for you. You should ask your LASIK doctor how long 
343  you should refrain from participating in certain activities following surgery. You should 
11 
  Contains Nonbinding Recommendations 
 
Draft  Not for Implementation 
 
344  also discuss with your doctor steps you can take to decrease the risk of flap dislocation or 
345  loss. 
346   
347    Controlled autoimmune or connective tissue disease. Connective tissue diseases or 
348  autoimmune diseases (such as rheumatoid arthritis and lupus), even if well controlled and 
349  stable, may result in delayed healing and less predictable outcomes after LASIK. 
350  Depending upon your disease, its severity, and the medication(s) you are taking, there 
351  may be additional risks. These may include severe dry eye, infection, inflammation, poor 
352  healing, and corneal melting. You should discuss these additional risks with your LASIK 
353  doctor, after he or she has consulted with the other doctors who are treating you.  
354   
355    Taking isotretinoin. This medication, usually used for acne treatment, increases your 
356  risk for dry eye and abnormal wound healing after LASIK. If you have taken or plan to 
357  take this medication, talk to your LASIK doctor and the doctor prescribing this 
358  medication about your risk.  
359   
360    Controlled diabetes. Even if your diabetes is well controlled, you may have poor healing 
361  of your eye following LASIK.    
362   
363    Repeated attacks of sharp eye pain due to epithelial basement membrane dystrophy 
364  (EBMD). In this condition, the outer layer of corneal cells does not stick well to the other 
365  corneal layers causing the outer cells to rub off easily. These recurring scratches 
366  (recurrent erosions) on the eye surface often cause blurred vision, pain, light sensitivity, 
367  and tearing. LASIK is likely to worsen EBMD. Let your LASIK doctor know if you have 
368  had these symptoms in the past, and ask if any signs of this condition have been noted on 
369  your eye exam. 
370   
371    Weakened immune system. If you have a weakened immune system due to medications 
372  (such as steroids) or a medical condition (such as AIDS), you may be more prone to 
373  infection after surgery. Such conditions and medications may put you at greater risk for 
374  other complications as well, such as dry eye or abnormal wound healing. Let your LASIK 
375  doctor know about any medical conditions you have and all medications you are taking. 
376   
377    History of crossed eyes (strabismus). If you are having LASIK for farsightedness and 
378  have a history of crossed eyes (strabismus), you may be at an increased risk of having 
379  double vision after surgery. Tell your LASIK doctor if you have ever had crossed eyes 
380  or double vision. 
381   
382    Decreased vision in one eye. If you have one eye that does not see clearly, even with 
383  glasses, you should discuss this with your LASIK doctor. This condition can be due to 
384  amblyopia, a lazy eye, or damage from an injury or disease.  With this type of 
385  decreased vision in one eye, complications that might result from LASIK in your better 
386  seeing eye could more severely impact your functioning. 
387   
388   
12 
  Contains Nonbinding Recommendations 
 
Draft  Not for Implementation 
 
389  c.  Other Things That May Increase Your Risk of LASIK Complications 
390  (Precautions) 
391  This part of the labeling should include precautionary statements, which can provide information 
392  regarding any special care to be taken by the doctor and/or patient to avoid mild or moderate 
393  harms. This section should include precautionary statements concerning conditions that could 
394  affect the outcomes of LASIK and are less likely to occur or are less serious than those discussed 
395  under Warnings. The precautions should include information about other considerations that 
396  could affect eye health, as well as patient characteristics not studied in the pivotal study, but for 
397  which adverse outcomes would not be expected with use (e.g., based on the inclusion and 
398  exclusion criteria and not already reflected in the Contraindications and Warnings). The 
399  following is one example of a set of precautions that follow the above recommendations: 
400   
401  The list below provides information regarding conditions for which consideration should be 
402  given when deciding whether the benefits of LASIK with this device outweigh the risks to 
403  you. You should discuss with your LASIK doctor whether the following conditions apply to 
404  you and how they may affect your risk of having complications from LASIK:  
405   
406  *  Family history of thinning of the cornea. Eye diseases like a cone-shaped cornea 
407  (keratoconus), thinning of the inferior part of the cornea (pellucid marginal 
408  degeneration), and other conditions that may cause a thinning or bulging of the cornea 
409  can run in families. You may not be aware that you have such a condition if it is in the 
410  early stage. If you have one of these conditions and it has not been diagnosed, LASIK 
411  may cause more rapid progression of the disease. You should tell your LASIK doctor 
412  about any family history of these or any other eye problems.  
413   
414  *   History of any eye disease (e.g., uveitis), abnormality, injury, or surgery. If you have 
415  a history of any of these conditions, you should discuss them with your LASIK doctor, as 
416  they might increase the risks of LASIK. For example, corneal scars may affect LASIK 
417  accuracy and vision following the surgery.  
418   
419  *  Taking amiodarone hydrochloride. This medication, usually used to treat irregular 
420  heartbeats (ventricular arrhythmias), can cause cloudy areas in the cornea and may cause 
421  problems with healing after LASIK. Tell your LASIK doctor about all the medications 
422  that you are taking. 
423   
424  *  Taking sumatriptan.  This medication, usually used to treat migraine headaches, may 
425  cause problems with healing after LASIK. Tell your LASIK doctor about all medications 
426  you are taking.  
427   
428  *  Large pupils or very nearsighted. Many factors affect whether someone might 
429  experience visual symptoms, making it difficult to predict who will experience them after 
430  surgery.  However, very nearsighted patients and patients with large pupils may be at 
431  greater risk of experiencing visual symptoms, such as halos and glare. In addition, 
432  patients who are very nearsighted generally may have less accurate correction than those 
13 
  Contains Nonbinding Recommendations 
 
Draft  Not for Implementation 
 
433  requiring less treatment. Ask your doctor whether you have large pupils or are very 
434  nearsighted. 
435  
436  *  Activities under poor lighting conditions. LASIK may decrease your ability to see well 
437  in poor lighting conditions, such as in dim lighting, rain, snow, and fog, when contrast 
438  (difference in how bright an object is compared to its background) is low, or when there 
439  is glare from bright lights, especially at night. You should discuss these potential 
440  problems with your LASIK doctor. After LASIK, you should be careful while driving 
441  when you are in poor lighting conditions until you can determine whether you have any 
442  difficulties.  
443   
444  *  Allergies or eye rubbing. If you rub your eyes after you have had LASIK, you are at a 
445  greater risk for dislodging the LASIK flap. This is because the strength of the attachment 
446  of the flap to the underlying corneal layers is permanently reduced after surgery. 
447  Additionally, some allergy medications cause dry eye symptoms. If you take these 
448  medicines, you are at greater risk for severe dry eye after LASIK. Let your LASIK doctor 
449  know about all your allergies and medications (even over-the-counter medications) and if 
450  you tend to rub your eyes frequently. 
451   
452  *  Elevated eye pressure (ocular hypertension) or being followed for possible 
453  glaucoma. If you have either of these conditions related to eye pressure, there are several 
454  ways LASIK can cause problems for you. It is more difficult to accurately monitor your 
455  eye pressure after LASIK, which may delay the detection of glaucoma. You may be at 
456  greater risk for damage to your vision associated with cutting the LASIK flap. 
457  Additionally, steroid drops used after surgery may raise the eye pressure and cause 
458  glaucoma to worsen. Let your LASIK doctor know if you have any of these conditions.   
459    What are the Risks?  
460  This part of the labeling should include a description of patient risks. FDA recommends that the 
461  most severe and most frequent potential risks and complications, both associated with LASIK in 
462  general and with the device to be used, are discussed first, followed by all others (e.g., 
463  headaches, reading difficulty). Manufacturers should define all medical terms used in this section 
464  in a glossary and include every medical term in parentheses in the text following a plain 
465  language description of the term. FDA recommends including clearly labeled images to help 
466  explain visual symptoms when possible. The following is one example of a set of risk 
467  descriptions that follow the above recommendations: 
468   
469  Some problems that patients experience after LASIK commonly occur right after surgery and 
470  are usually greatly reduced within 3 to 6 months. However, in some patients these problems 
471  can be permanent and, in rare cases, may impact their ability to perform daily tasks.  
472   
473  The risks of LASIK include, but are not limited to, the following: 
474   
475    Loss of vision. This means that vision becomes unclear (blurry or hazy vision) even with 
476  glasses or contact lenses. Your doctor may be able to measure this loss using a vision 
14 
  Contains Nonbinding Recommendations 
 
Draft  Not for Implementation 
 
477  chart. The loss may be mild or, in rare cases, severe. In extremely rare cases, people can 
478  experience a total loss of vision. Vision loss is usually temporary, but there are 
479  complications of LASIK that can cause permanent loss of vision. How clearly you can 
480  see may change from day-to-day or even from minute-to-minute (fluctuating vision). 
481  Some of the potential causes of vision loss following LASIK are discussed below.  
482    
483    Corneal complications. The following corneal complications may lead to permanent 
o
484  vision loss, for example, due to loss of corneal clarity from scarring or swelling, and 
485  may require corneal transplant surgery for treatment: 
486   
487    Corneal flap complications. LASIK requires the cutting of a flap of the front-
488  most part of the cornea. The flap is swung out of the way so the laser can treat 
489  underlying tissue, and is returned to its original position after the treatment. Flap 
490  complications include irregular cutting of the flap, the flap not properly returning 
491  to its original position, the flap coming off and even getting lost, and irregular 
492  healing. If a flap complication occurs during surgery, the surgery may need to be 
493  interrupted and rescheduled. A flap complication can result in the need for 
494  additional surgery or, rarely, permanent loss of vision. In almost all LASIK cases, 
495  the strength of the flaps re-attachment to the underlying tissue is significantly and 
496  permanently weaker than before LASIK. There are reports of the flap being torn 
497  off, even many months after surgery. It may be necessary to wear protective 
498  eyewear during certain physical activities like contact sports. 
499   
500    Infection. The cornea may get infected right after surgery. This can be treated 
501  with topical medication, which may or may not successfully control the infection. 
502  On rare occasions, an infection may cause a hole in the clear covering of the eye 
503  (perforation of the cornea). 
504   
505    Inflammation. Inflammation after LASIK is the bodys reaction to such things as 
506  tissue disruption from surgery or infection. Excessive inflammation of the cornea 
507  can cause scarring or swelling resulting in cloudiness or haziness (loss of corneal 
508  clarity). 
509   
510    Irregular corneal shape. LASIK or the healing process after surgery may result 
511  in an irregular shape to the cornea. This can cause blurry vision or other visual 
512  symptoms. Such irregularities in shape can be measured by your doctor using 
513  special instruments. 
514   
515    Bulging of the cornea (corneal ectasia) is the most extreme irregularity. This 
516  complication is uncommon, but can cause permanent and significantly blurry 
517  vision, sometimes requiring a corneal transplant. 
518   
519    Retinal detachment. The retina is the light-sensitive tissue that lines the inside back 
o
520  of the eye and captures images that are transmitted to the brain, much like the film of 
521  a camera. If the retina detaches, or comes unglued from its attachments within the 
15 
  Contains Nonbinding Recommendations 
 
Draft  Not for Implementation 
 
522  eyeball, it will lose its function and need to be reattached through surgery. This may 
523  result in permanent loss of vision, even if the retina is successfully reattached. Retinal 
524  detachment after LASIK is rare, and usually only occurs in people who are very 
525  nearsighted and are prone to this type of retinal problem.  
526   
527    Dry eyes. LASIK may cause or increase eye dryness, which may also cause discomfort 
528  and visual problems. The doctor may see dry spots on the normally-moist portions of the 
529  cornea, or surface damage caused by dryness. These problems usually improve within 3 
530  to 6 months, but in rare cases never go away.  
531   
532  If you have dry eye before surgery, LASIK may increase dry eye symptoms and related 
533  problems after surgery. Your doctor should test you for pre-existing dry eye. However, 
534  there is no test that can guarantee whether you will, or will not, have dry eye after 
535  LASIK. Lubricating drops are usually necessary immediately after surgery to help with 
536  dryness. Symptoms of dry eye may include a scratchy or sandy feeling as if something is 
537  in your eye, stinging, burning, episodes of excessive tearing, a stringy discharge from the 
538  eye, pain, redness, light sensitivity, and blurred vision. The sensation of dryness can vary 
539  from mild to severe, but in most cases the feelings are a minor annoyance. Eye drops 
540  such as artificial tears, or other treatments, such as plugs in the tear drainage system of 
541  the eye, may reduce these symptoms, but may not completely resolve them. A small 
542  number of patients experience extreme discomfort that interferes with their ability to do 
543  daily tasks. 
544   
545    Discomfort or pain. It is not unusual for patients to have some mild discomfort right 
546  after LASIK, but it usually goes away within a few weeks or months. Complications like 
547  dry eye, inflammation, or infection may cause severe, constant pain in some patients, 
548  preventing them from doing their normal activities. In some patients, the pain may 
549  never go away (i.e., chronic pain) and may be resistant to therapy.  
550   
551    Visual Symptoms. LASIK may cause or worsen visual symptoms, such as glare, halos, 
552  starbursts, and ghost images/double images, most commonly experienced in dim lighting 
553  conditions as well as blurred and fluctuating vision. These problems usually improve 
554  within 3 to 6 months after surgery, but in some cases never go away, even when glasses 
555  are worn. Visual symptoms can be mild, but can also be severe enough to cause 
556  difficulties in performing daily tasks. A common complaint is difficulty with driving at 
557  night. Specific visual symptoms are described below with images to help explain the 
558  visual symptoms. The images shown may not represent exactly what you might see, and 
559  your symptoms may be more or less severe than what is shown:  
560   
561    Glare. Glare is difficulty seeing well when there are bright lights like headlights or 
o
562  sunlight, as shown in the images below.   
563   
16 
  Contains Nonbinding Recommendations 
 
Draft  Not for Implementation 
 
564   
565   
566    Halos. You may see halos. By halos, we mean seeing a fuzzy cloud of light around 
o
567  lighted objects, such as the ones shown in the images below.    
568   
569   
570   
571    Starbursts. You may see rays of light coming from lighted objects, such as in the car 
o
572  headlights in the images below.  
573   
574   
17 
  Contains Nonbinding Recommendations 
 
Draft  Not for Implementation 
 
575   
576    Double vision. Double vision, which some people call ghost or shadow images, 
o
577  are distorted or blurry visual images, such as the ones shown below. If you 
578  experience such images, close one eye and then the other to determine if you only see 
579  the double images with both eyes open. If you still have double vision with one eye 
580  closed, note in which eye you are experiencing the double images. This information is 
581  important to report back to your doctor to help him or her determine the cause of the 
582  problem.   
583   
584   
585   
586    Decreased ability to see under low lighting conditions. You may have more 
o
587  difficulty seeing in low lighting conditions after surgery than before surgery. For 
588  example, some patients describe having more trouble reading the menu in a dimly lit 
589  restaurant or climbing down stairs in a theater. Driving during certain periods of the 
590  day, such as dusk and dawn, may become difficult, because of trouble reading signs, 
591  distinguishing the curb from the road, and being able to see people crossing the street.  
592  Some people have reported having so much difficulty seeing under these types of 
593  conditions that they avoid doing certain activities.     
594   
595    Potential risk of psychological harm. There have been reports that some patients who 
596  have had LASIK have experienced severe depression or suicidality that they believe to be 
597  a result of complications following the procedure. A definitive causal link between 
598  LASIK and these reported psychological harms has not been established.  
599   
600    Desired correction not achieved or does not last. LASIK may not result in the desired 
601  amount of vision correction, or the level of vision correction may decrease over time. 
602  Additional corrective surgery may not always be possible, and when it is possible may 
603  not result in the desired correction. Even if your vision results are generally good, you 
604  may still need glasses or contact lenses to perform certain tasks.  
605   
606    Unintentional imbalance between two eyes. LASIK may cause an imbalance between 
607  the two eyes if the desired correction is not achieved, or one eye is treated with LASIK 
18 
  Contains Nonbinding Recommendations 
 
Draft  Not for Implementation 
 
608  but the other eye cannot undergo LASIK. Imbalances between the two eyes may cause 
609  headaches, eyestrain, double vision, and reduced depth perception, if both eyes are not 
610  able to focus at the same time at the same distance (anisometropia).  
611   
612    Need for glasses for close work. Almost all people in their 40s or older lose their ability 
613  to focus from far to near. LASIK does not treat this condition (called presbyopia). After 
614  surgery, patients who are already over 40 years old (or once they reach their 40s) usually 
615  need to wear glasses for close work, such as reading, even if they did not need to wear 
616  them before surgery. 
617   
618    Drooping eyelid. The lid of the eye(s) that had surgery may droop. This can be a 
619  complication from an instrument used to hold the lid during surgery. Besides the 
620  appearance of unevenness in the height of the eyelids, this may result in a feeling of the 
621  eyes getting tired during the course of the day or difficulty seeing, and may require eyelid 
622  surgery.  
623   
624    Future eye health. LASIK will likely cause difficulties with:  
625   
626    Future assessment of eye pressure. Thinning of the cornea due to LASIK will affect 
o
627  your eye pressure measurements (used as part of the exam for glaucoma), making 
628  them more difficult to interpret. You should inform all eye care providers that you 
629  have had LASIK.  
630   
631    Future cataract surgery. Almost everyone needs cataract surgery (removal of your 
o
632  natural lens) later in life. LASIK may make it more difficult for the surgeon to 
633  implant the correct artificial lens. You should ask your LASIK doctor for a patient 
634  information card (e.g., the K-Card found at 
635  http://www.geteyesmart.org/eyesmart/upload/kcard.pdf) that lists your eye 
636  measurements before you have LASIK. You should keep this card to help the cataract 
637  surgeon accurately calculate the artificial lens power you will need when you have 
638  cataract surgery in the future.  
639   
640  See the Clinical Study Section to find out how often specific problems occurred in those 
641  treated with the [XX] laser in clinical studies of the device.  
642    What to Expect Before, During, and After Surgery 
643  This part of the labeling should include a description of what a patient should expect before (e.g., 
644  informing the LASIK doctor about all medications and all eye and medical conditions, 
645  discontinuation of contact lens wear, typical preoperative instructions), during, and after a 
646  surgical procedure, including typical postoperative care instructions (e.g., medications, 
647  limitations on activities). It is also recommended that approximate postoperative times that 
648  various symptoms may be experienced are included in this part of the labeling, along with 
649  explanations of what symptoms may be indicative of adverse events and under what 
650  circumstances patients should contact their doctors.  
19 
  Contains Nonbinding Recommendations 
 
Draft  Not for Implementation 
 
651    Clinical Study Information 
652  This part of the labeling should include descriptions of clinical study information relevant and 
653  specific to the LASIK device to be used in the procedure. The clinical study information 
654  provides specific context about the LASIK device to be used in the procedure, such as rates and 
655  types of adverse events and visual symptoms, and patient reported outcomes. Given the 
656  complexities of clinical studies, this information should be described in a way that is meaningful 
657  to patients and easy to understand. Tables, graphs, and other technical information should be 
658  made as readable and understandable at a glance to the patient as possible, and should 
659  complement any textual descriptions. FDA recommends using lay terms rather than technical 
660  words and acronyms, that all symbols and abbreviations included in the tables and graphs be 
661  clearly defined, and that any tables or graphs contain brief explanations of what information is 
662  shown. 
663   
664  FDA recommends including the purpose and main objectives of the study in this part of the 
665  labeling, which should contain a very brief description of the general study design, including the 
666  number of months that patients were followed, the number of patients studied, the key evaluation 
667  time points, and the primary and secondary safety and effectiveness endpoints.  
668   
669  Further, the key safety and effectiveness outcomes of the study should be summarized in lay 
670  terms, including tabulation and accompanying explanation of the adverse events and 
671  complications that occurred during the course of the trial, symptoms, and any patient-reported 
672  outcomes. FDA recommends that you do not use percentages to summarize the outcome 
673  information, but rather the actual number of subjects in the numerator and denominator to 
674  represent rates (e.g., 45 of the 302 patients seen at the 12-month visit), when applicable. 
675  Results of contrast sensitivity testing should be briefly summarized in lay terms with the number 
676  of subjects that underwent testing and the outcomes from the perspective of whether losses were 
677  experienced under each of the various testing conditions. 
678    Contact Information 
679  This part of the labeling should contain the manufacturers contact information, including the 
680  address and phone number, as well as blank lines that can contain the providers and surgical 
681  centers names, addresses, and phone numbers. 
682    Patient Decision Considerations 
683  FDA believes that a patient decision checklist highlighting key risk information should be 
684  included at the end of the patient labeling. To help ensure the material is reviewed, FDA 
685  recommends the checklist allow for patients and physicians to affirmatively acknowledge (e.g., 
686  via initials and/or signatures) that specific information was read and discussed. Additionally, 
687  FDA recommends that it should be printed in a fashion where it can be easily separated and 
688  marked.  
689  To help ensure the checklist is read and understood by patients, FDA is providing 
690  recommendations regarding content and organization below. First, in the introduction for the 
691  checklist, FDA recommends including a description of the purpose and importance of the 
20 
  Contains Nonbinding Recommendations 
 
Draft  Not for Implementation 
 
692  checklist, as well as instructions to the patient on how to review and complete the document 
693  prior to deciding whether to undergo the procedure. Next, to achieve the goals described above, 
694  FDA recommends that each topic grouping in the body of the checklist be accompanied by a line 
695  for the patient to initial indicating acknowledgment and understanding of that information. At the 
696  end, FDA recommends including a section that confirms that the patient has read the patient 
697  labeling material and has had the opportunity to satisfactorily discuss the patients risks with his 
698  or her eye surgeon. This should be followed by a signature line for the patient. At the end of the 
699  checklist, FDA recommends having a section that confirms that the physician discussed the 
700  benefits, risks, and alternatives of the device, as set forth in the patient labeling, including the 
701  patient decision checklist, with the patient. FDA recommends that this be followed by a signature 
702  line for the physician.  
703   
704  The FDA recommends that a copy of the patient decision checklist be provided to the patient so 
705  that the patient can refer back to this important information. The FDA also encourages device 
706  manufacturers to develop a plan to ensure that patients are adequately informed of the risks of 
707  LASIK.  
708   
709  Appendix A provides an example of a patient decision checklist. FDA believes that the form and 
710  content of the patient decision checklist will help to ensure that patients have adequate and 
711  salient information about the risks and warnings of LASIK surgery, with appropriate prominence 
712  and conspicuousness such that it is easily read and understood. The rates of certain adverse 
713  events identified in the patient decision checklist were based on information from clinical trials, 
714  scientific literature, and reports from patients who have undergone LASIK. FDA recommends 
715  using these rates unless compelling data regarding the rates of certain events have been collected 
716  with post-market experience on a specific device, particularly for the more rare adverse events.   
717     
21 
  Contains Nonbinding Recommendations 
 
Draft  Not for Implementation 
 
Appendix A: Patient Decision Checklist Example 
718 
719   
720  To the patient considering LASIK surgery: 
721   
722  The review and understanding of this document is a critical step in making the decision whether 
723  you should choose LASIK surgery. You should carefully consider the benefits and risks 
724  associated with the surgery before you make that decision. This form lists important risks, 
725  including those known or reported to be associated with the use of the LASIK laser devices 
726  based on information from clinical trials, scientific literature, and reports from patients who have 
727  undergone LASIK. After reviewing the information in the patient labeling for the specific 
728  LASIK laser that will be used, please read and discuss the items in this checklist with your 
729  doctor. You should place your initials in the location provided next to each item to indicate that 
730  you have read and understood the item. Your full signature at the end of this document means 
731  that you have read and understood the materials and that your physician has answered all 
732  questions to your satisfaction.  
733   
734  Vision Correction Options 
735  I understand that eyeglasses or contact lenses are proven methods for vision correction, and that 
736  photorefractive keratectomy (PRK) is an alternative surgical method for vision correction. I also 
737  understand that small incision lenticule extraction (SMILE) may be another surgical alternative 
738  for me if I am nearsighted, and conductive keratoplasty may be an alternative procedure for me if 
739  I am farsighted. I was also informed of the associated benefits and risks of other alternatives. 
740  I understand that LASIK may not result in the desired amount of vision correction. Even if my 
741  vision results are generally good, I may still need glasses or contact lenses to perform certain 
742  tasks, and the results achieved may decline over time.  
743   
744  I understand that during LASIK surgery, a flap is cut in the cornea and corneal tissue is 
745  vaporized.  
746    Corneal tissues and nerves cut during this process must heal following surgery. Corneal 
747  nerves may not fully recover resulting in dry eyes and/or chronic pain.  
748    Even after the corneal flap has fully healed, the cornea will not be as strong as it was 
749  before surgery. 
750   
751  Patient Initials: _________ 
752   
753  Considerations for a good candidate for LASIK surgery 
754  I understand that I should not have LASIK surgery while I have an active eye inflammation or 
755  infection. 
756   
757  I understand that I am not a good candidate for LASIK if:   
758    I have severe dry eyes. 
759    My cornea(s) is not thick enough. 
22 
  Contains Nonbinding Recommendations 
 
Draft  Not for Implementation 
 
760    My doctor has told me that I have a condition that causes thinning or bulging of the 
761  cornea, such as keratoconus or pellucid marginal degeneration. 
762    I have problems resulting from a past herpes eye infection. 
763    I have an autoimmune disease or connective tissue disease (like lupus or rheumatoid 
764  arthritis), glaucoma, or diabetes. 
765   
766  Patient Initials: _________ 
767   
768  What to Expect in the First Six Months. 
769  I understand that dry eye following surgery is common, and the symptoms of dry eye, including 
770  blurred vision, can vary from mild to severe. Based on the estimates below, I am prepared to 
771  regularly use lubricating eyedrops to manage dry eye symptoms. 
772   
773  I understand that, following LASIK surgery, estimates of certain common risks are as follows: 
774    One (1) week following surgery, up to 85% of patients experience dry eye symptoms.  
775    At six (6) months following surgery: 
776    Up to 27% of patients experience dry eye symptoms. 
o
777    About 41% of patients may experience visual symptoms such as glare, halos, 
o
778  starbursts, and double images, as illustrated in Figure 1 (with or without glasses or 
779  contact lenses).  
780    Around 4% of patients may have very or extremely bothersome symptoms. 
o
781    Around 2% may have a lot of difficulty or so much difficulty that I can no 
o
782  longer do some of my usual activities when not wearing glasses or contact 
783  lenses. 
784   
785   
786   
787  Patient Initials: _________ 
788   
789  Long-term Risks 
790    I understand that, although rare, there have been reports that some patients who have had 
791  LASIK have experienced severe depression or suicidality that they believe to be a result 
792  of complications following the procedure. A definitive causal link between LASIK and 
793  these reported psychological harms has not been established.  
794    I understand that dry eye may persist beyond six (6) months.  
795    I acknowledge the following estimates of the percentage of patients experiencing the 
796  persistence of certain symptoms five (5) years after surgery: 
23 
  Contains Nonbinding Recommendations 
 
Draft  Not for Implementation 
 
797   
798    Around 17% of patients may still need to use eye drops daily for dry eye. 
o
799    Less than 2% of patients notice some visual disturbance, such as glare, halos, 
o
800  starbursts, and double vision.  
801    A decreased ability to see under low light conditions; around 8% of patients may 
o
802  have moderate difficulty or a lot of difficulty driving at night. 
803    Very rare reports (estimated rate of less than 0.8%) of severe, constant pain that 
o
804  may prevent normal activities.  
805   
806  Patient Initials: _________ 
807     
24 
  Contains Nonbinding Recommendations 
 
Draft  Not for Implementation 
 
808  CONFIRMATION OF DISCUSSION OF RISKS 
809  Patient: I acknowledge that I have received and read the patient labeling for the specific LASIK 
810  laser that will be used during my LASIK surgery and that I have had time to discuss the items in 
811  it and on this document with my doctor. I have had the opportunity to ask questions and 
812  understand the benefits and risks of LASIK surgery for me, given my specific health conditions.  
813  I have considered alternatives to LASIK, such as contact lenses, eyeglasses, and PRK, and their 
814  risks and benefits.  
815   
816   
817   
818   
819  Patient Signature and Date 
820   
821  Physician: I acknowledge that I have discussed the benefits and risks of LASIK as described in 
822  the patient labeling, including this patient decision checklist. I have also explained the benefits 
823  and risks of the alternatives. I have encouraged the patient to ask questions, and I have addressed 
824  all questions. 
825   
826   
827   
828   
829  Physician Signature and Date   
830   
25