Guidance for Industry and  
Food and Drug Administration 
Staff 
Contact Lens Care Products 
Labeling 
 
Document issued on: August 15, 2010  
 
This document is an addendum to that portion of the GUIDANCE FOR 
LABELING OF CONTACT LENS CARE PRODUCTS IN 510(K) 
MARKETING CLEARANCE APPLICATIONS THAT 
SPECIFICALLY ADDRESSES THE PRODUCT LABELING AND 
INSTRUCTIONS FOR USE BY THE CONSUMER. 
May 1, 1997 
 
For questions regarding this document, contact Tina Kiang, Ph.D. at 301-796-5620 or via email 
at tina.kiang@fda.hhs.gov 
 
 
 
 
 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Devices and Radiological Health 
Office of Device Evaluation 
Division of Ophthalmic, Ear, Nose and Throat Devices 
Intraocular, Corneal and Neuro-materials Devices Branch  Contains Nonbinding Recommendations 
 
Preface 
 
Public Comment 
 
You may submit written comments and suggestions at any time for Agency consideration to 
the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, 
Room 1061, (HFA-305), Rockville, MD, 20852.  Submit electronic comments to 
www.regulations.gov.  When submitting comments, please refer to the exact title of this 
guidance document.  Comments may not be acted upon by the Agency until the document is 
next revised or updated.   
 
Additional Copies 
 
Additional copies are available from the Internet at: 
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/uc
m1725.htm.  You may also send an e-mail request to dsmica@fda.hhs.gov to receive an 
electronic copy of the guidance or send a fax request to 301-827-8149 to receive a hard copy.  
Please use the document number 1725 to identify the guidance you are requesting. 
 
 
  Contains Nonbinding Recommendations 
 
Table of Contents 
1.  INTRODUCTION .................................................................................................................... 1 
2.  SCOPE ...................................................................................................................................... 1 
3.  GENERAL CONSIDERATIONS ............................................................................................ 2 
4.  SUGGESTED CONTENT OF PATIENT LABELING ........................................................... 3 
A.  GLOSSARY ............................................................................................................................. 3 
B.  EMPHASIZED INSTRUCTIONS FOR USE AND WARNINGS .......................................... 3 
C.  EMPHASIZING THE THE RISKS .......................................................................................... 6 
 
 
   
 
  Contains Nonbinding Recommendations 
 
Guidance for Industry and  
Food and Drug Administration Staff (add 
others as appropriate, e.g., Third Parties) 
 
Contact Lens Care Products Labeling 
 
This guidance represents the Food and Drug Administration's (FDA's) current thinking 
on this topic.  It does not create or confer any rights for or on any person and does not 
operate to bind FDA or the public.  You can use an alternative approach if the approach 
satisfies the requirements of the applicable statutes and regulations.  If you want to discuss 
an alternative approach, contact the FDA staff responsible for implementing this 
guidance.  If you cannot identify the appropriate FDA staff, call the appropriate number 
listed on the title page of this guidance.  
 
1.  Introduction 
This guidance document is an addendum to a special control guidance that supports the 
classification of the Contact Lens Care Products as class II (special controls).  
 
FDA's guidance documents, including this guidance, do not establish legally enforceable 
responsibilities.  Instead, guidances describe the Agency's current thinking on a topic and 
should be viewed only as recommendations, unless specific regulatory or statutory 
requirements are cited.  The use of the word should in Agency guidances means that 
something is suggested or recommended, but not required. 
 
2.  Scope 
The scope of this document is limited to the devices described below. 
 
21 CFR 886.5918 Rigid gas permeable contact lens care products. 
 
Product Codes: 
 MRC  products, contact lens care, rigid gas permeable 
 
(a) Identification. A rigid gas permeable contact lens care product is a device 
intended for use in the cleaning, conditioning, rinsing, lubricating/rewetting, or 
storing of a rigid gas permeable contact lens. This includes all solutions and tablets 
used together with rigid gas permeable contact lenses. 
 
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(b) Classification. Class II (Special Controls) Guidance Document: "Guidance for 
Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care 
Products." 
 
21 CFR 886.5928 Soft (hydrophilic) contact lens care products 
 
Product Codes: 
 LPN  accessories, soft lens products  
 LYL  accessories, solution, ultrasonic cleaners for lenses 
 LRX  case, contact lens 
 HRD  sterilizer, soft-lens, thermal, ac-power 
 HRC  sterilizer, soft-lens, thermal, battery 
 
(a) Identification. A soft (hydrophilic) contact lens care product is a device intended 
for use in the cleaning, rinsing, disinfecting, lubricating/rewetting, or storing of a soft 
(hydrophilic) contact lens. This includes all solutions and tablets used together with 
soft (hydrophilic) contact lenses and heat disinfecting units intended to disinfect a 
soft (hydrophilic) contact lens by means of heat. 
 
(b) Classification. Class II (Special Controls) Guidance Document: "Guidance for 
Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care 
Products." 
 
This document provides additional guidance on strengthening warnings and directions for 
use labeling of contact lens care products (e.g., contact lens solutions, lens cases, and contact 
lens accessories) described in the 1997 guidance document.  
 
3.  General Considerations 
Patient information labeling includes information contained on the outside packaging, 
package insert and primary container and is directed to the contact lens wearer. The patient 
labeling should instruct the patient on product care to ensure lenses are used safely and 
effectively, potential risks and benefits, and what to expect when they use these care 
products. When translating information from professional terminology into lay language, the 
manufacturer should not alter the intent of the indications, contraindications, warnings and 
precautions. The labeling should contain sufficient information to describe the device, its 
intended use, and specific descriptions of the patients for whom the product would not be a 
good choice (e.g., allergy to specific components of the product(s)).  
 
The lay language should provide a balanced presentation of adverse events and the risks and 
benefits of the device. It should not introduce new device performance claims that were not 
cleared in the pre-market notification submission. Patient information labeling, if possible, 
should not exceed the eighth grade reading comprehension level. 
 
To increase the likelihood that the patient labeling will be provided to the patient and be read 
by the patient, consider: 
2   Recommending that all eye care professionals review this labeling with their patients.
 Placing patient labeling on your web site, if you maintain one, to help patients get the
most up-to-date information.
For specific directions on writing effective labeling for devices, please refer to the April 19, 
2001 Office of Communication, Education, and Radiation Programs (OCER) Guidance on 
Medical Device Patient Labeling1. We recommend reviewing the Recommended Content 
of an Effective Warning or Precaution section on page 40 of 54 of that document.  
4. Suggested Content of Patient Labeling
In addition to the information contained in the current special controls guidance, we 
recommend that the patient labeling contain the following sections to aide the users 
understanding of proper use and care of these devices.  FDA views this information as 
critical to the safe use of contact lenses. 
A.Glossary
The use of a brief glossary is highly recommended. It should be placed after the table of 
contents to alert readers that it is there to help them. Words or phrases that are explained 
in the Glossary are generally identified at each occurrence in the text by highlighting 
with italics, or bolding, or etc., where possible. Whether or not a glossary is used, 
meanings of key words and phrases should appear in the text. 
B. Emphasized Instructions for use and warnings
Rub and Rinse 
Information presented at a June 2008 meeting of the FDAs Ophthalmic Devices 
Advisory Panel noted that the rub and rinse cleaning regimen helps prevent potentially 
infectious microbes from forming on the lenses. No-rub contact lens care products have 
always had directions for both rub and no-rub regimens, based on practitioners 
directions to their individual patients and their health care requirements.  
While there are scientific data that support both no-rub and rub-and-rinse cleaning 
regimens, there is evidence that the rub-and-rinse regimen results in a greater reduction 
in microbes. Some microbes interact with some of the silicone hydrogel contact lenses 
and adhere to the surface. Rubbing lenses may remove these microbes. However, there is 
a risk of contamination if users rub or otherwise handle their contact lenses without 
thoroughly washing their hands. 
1 https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/
GuidanceDocuments/UCM070801.pdf 
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We recommend that manufacturers of contact lens multi-purpose solution products that 
include no rub directions remove the no-rub from product labeling and emphasize 
the importance of rubbing and rinsing in caring for contact lenses.  Our 
recommendation is consistent with several professional eye organizations. 
 
In the interest of improving lens care hygiene, we recommend that the directions for use 
also include a rinse step before placing the lenses on the eye.  Any debris remaining on 
contact lenses following the soaking step that is potentially clinically significant may not 
be readily visible to the user.  We recommend that this direction appear on the bottle for 
easy reference by the user. 
 
The Quality System Regulation 21 CFR 820.30 requires that manufacturers establish and 
maintain design controls to ensure adherence to specified design requirements. Labeling 
for this product should provide adequate directions for use (e.g., rubbing and rinsing 
times for daily cleaning, soak times for disinfection, and maximum storage times 
following disinfection) for all intended uses identified above. While labeled rubbing or 
rinsing times are usually consistent with those used in pre-clinical microbiology testing, 
we also recommend that these times not be excessive to diminish compliance by the user.  
In order to address the needs of the user, we recommend that you consider reasonable 
rinse times as a design input to address the needs of the user.   
 
For example, a labeling direction for the user to rinse each side of the lens for 10 
seconds, or a combined total of 20 seconds, may not be a realistic expectation for users to 
comply.  Excessively prolonged rinse times do not provide the type of device information 
that would foster patient compliance with directions for use. 
 
Multi-Purpose   
We recommend that multi-purpose products be for cleaning, disinfecting, storing and 
rinsing only.  A contact lens solution that cannot perform all of the functions indicated in 
the labeling should not be labeled as a multi-purpose contact lens care solution. 
 
As discussed in the 1997 Guidance, we do not recommend that a multi-purpose solution 
be labeled as an ALL-IN-ONE solution since lubricating and rewetting drops or enzyme 
treatments used for complete lens care are not functions of a multi-purpose solution.  
 
The 1997 Guidance also addressed the concern regarding contamination as a basis for not 
recommending that multi-purpose solutions be labeled for lubricating and rewetting 
lenses during wear even if the chemical compositions of the multi-purpose solution and 
lubricating and rewetting drops are identical. 
 
Current General Warning 
The current labeling guidance includes a recommendation that a consumer who develops 
an eye infection should immediately remove their lenses and promptly contact their eye 
care provider.  Often the warning is a single block of text, which is not easily readable. 
We recommend formatting to enhance readability.  We also recommend that the labeling 
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advise the user to bring their lenses, solutions and lens case with them to their eye care 
provider for culturing in order to better establish the identity of any organism associated 
with the patients infection. 
 
Current Precautions 
We recommend that this section be organized by individual precautions, listed separately.  
Manufacturers of currently marketed products are encouraged to update their labeling in 
a similar manner at the next printing of the labeling. 
 
Labeling Enhancements 
Based on input and recommendations from the Ophthalmic Devices Advisory Panel we 
recommend that each of the following topics be addressed in the section of your labeling 
that addresses product care.  Note that while some current labeling may provide for 
similar statements in the instructions for use or in a safety tip section, very few currently 
include specific warnings to address these topics. 
 
Soaking and Storing Your Lenses 
Instruction for Use: 
Use only fresh multi-purpose (contact lens disinfecting) solution each time you soak 
(store) your lenses. 
  
Proposed WARNING: 
Do not reuse or top off old solution left in your lens case since solution reuse reduces 
effective lens disinfection and could lead to severe infection, vision loss or blindness.  
Topping-Off is the addition of fresh solution to solution that has been sitting your case.  
 
Note: We recommend that the re-use or topping off warning be printed on the product 
carton and bottle label as well as the package insert. 
 
Rub and Rinse Time 
Instruction for Use: 
  Rub and rinse your lenses for X seconds or more  (e.g., 10 seconds or more) and 
      then repeat with the second side for a total of 2  times X seconds (e.g., 20 seconds 
      or more.  
  Follow the complete recommended lens rubbing and rinsing times in the labeling 
      to adequately disinfect your lenses and reduce the risk of contact lens infection. 
 
Proposed WARNING: 
  Rub and rinse your lenses for the recommended amount of time to help prevent  
serious eye infections. 
  Never use water, saline solution, or rewetting drops to disinfect your lenses. These 
solutions will not disinfect your lenses. Not using the recommended disinfectant can 
lead to severe infection, vision loss or blindness. 
 
Lens Case Care 
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Instruction for Use: 
  Rinse your lens case with sterile contact lens solution (never use tap water) and 
      leave the lens case open to dry after each use. Turn the case over and shake any 
      excess solution out of the case. Be sure that no residual solution remains in the 
      case before you allow it to air dry.  
  Replace your lens case at least once every < insert a recommended time period >.  
      Contact lens cases can be a source of bacterial growth. 
 
Proposed WARNING: 
Do not store your lenses or rinse your lens case with water or any non-sterile solution. 
Only use fresh multi-purpose solution (or sterile saline solution) so you do not 
contaminate your lenses or lens case. Use of non-sterile solution can lead to severe 
infection, vision loss or blindness. 
  
Water Activity 
Instruction for Use:  
  Do not expose your contact lenses to water while you are wearing them.  
 
ProposedWARNING: 
Water can harbor microorganisms that can lead to severe infection, vision loss or 
blindness.  If your lenses have been submersed in water such as when swimming in 
pools, lakes, or oceans, you should discard them and replace them with a new pair. Ask 
your eye care practitioner (professional) for recommendations about wearing your lenses 
during any activity involving water.   
 
Discard Date 
Instruction for Use: 
  Discard any remaining solution < insert a recommended time period > after opening. 
 
Proposed WARNING: 
Using your multi-purpose solution beyond the discard date could result in contamination 
of the solution and can lead to severe infection, vision loss or blindness. 
 
Please note that labeling Appendix A of the 1997 guidance, page 65 contains a 
recommendation for including a fill in the line space on the bottle label for date opened 
or discard date.    
 
C. Emphasizing the Risks 
We recommend that the current general warning of eye infection emphasize the possible 
risks and complications that can be associated with use of contact lens care products 
when labeling directions are not accurately followed. You may wish to provide a photo of 
an infected eye. If you use this approach, it is important to emphasize that the photo is 
only demonstrating how serious a red eye can become. Please emphasize that the 
consumer should not ever wait until their eye looks like the picture before seeking 
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medical care. If an eye is red, has pain, blurry vision and persistent discomfort the 
labeling should direct the consumer to contact an eye care professional as soon as 
possible.  
 
. 
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