Health Care Professionals Participating at FDA

FDA Standard Content Version

Define 1-Day ACUVUE Brand Contact Lenses

Generated from J&J Labeling (August 2014)

“Cover” page includes the following:

Define 1-Day ACUVUE Brand Contact Lenses with Lacreon

etafilcon A Soft (hydrophilic) Contact lenses Cosmetically Tinted

with UV Blocker for Daily Disposable Wear

August, 2014

TABLE OF CONTENTS

1.0 Indications for Use

1.1 Purpose

1.1.1 Single use

1.1.2 Prescription use only

1.1.3 Where used

1.2 Intended Use Population

2.0 Individual Patient Selection Considerations

3.0 Contraindications

4.0 General Warnings and Precautions

4.1 Eye Problems Leading to Vision Loss

4.2 Specific Instructions for Use and Warnings about Water

Activity

4.3 UV Absorption and Radiation Exposure

4.4 Special Precautions for Eye Care Professionals

4.5 Instructions for Patients

4.5.1 Handling precautions

4.5.2 Lens wearing precautions

4.5.3 Lens care precautions

4.5.4 Emergencies

4.5.5 Other topics to discuss with patients

4.5.6 Who should know that the patient is wearing contact lenses?

5.0 Adverse Events

6.0 Device Description

6.1 Available Lens Parameters

Diameter

Center thickness

Base curve

Power range

6.2 Lens Properties

6.3 Oxygen Permeability

6.4 How Supplied

6.5 Theory of Operation

7.0 Instructions for Use

7.2 Preparation

7.2.1 General fitting guidelines

Pre-fitting examination

Initial power determination

7.2.2 Monovision fitting guidelines

Monovision needs assessment

Patient education

Eye selection

Ocular preference determination methods

Refractive error method

Visual demands method

Unilateral vision correction requirement

Near ADD determination

7.3 Use

7.3.1 Base curve selection (trial lens fitting)

Criteria of a properly fit lens

Criteria of a flat fitting lens

Criteria of a steep Fitting lens

7.3.2 Final lens power

7.3.3 Trial lens fitting – monovision

Adaptation

Other suggestions

7.4 After Use

7.4.1 Wearing schedule

7.4.2 Replacement schedule

7.4.3 Lens care directions

Basic instructions

Care for a sticking (non-moving) lens

7.4.4 Patient management

Dispensing visit

Follow-up examinations

Recommended follow-up examination

Recommended procedures for follow-up visits

12.0 Glossary

12.1 Symbols Key

13.0 Resources

Transmittance curves

Citations

14.0 Contact and Reporting Information

15.0 Date of Latest Revision

1.0 Indications for Use

1.1 Purpose

1.1.1 Single use

1.1.2 Prescription use only

1.1.3 Where used

Indicated for use in any clinical or non-clinical environment.

1.2 Intended Use Population

Indicated for use in the general population.

2.0 Individual Patient Selection Considerations

3.0 Contraindications

4.0 General Warnings and Precautions

4.1 Eye Problems leading to Vision Loss

4.2 Specific Instructions for Use and Warnings about Water

Activity

4.3 UV Absorption and Radiation Exposure

4.4 Special Precautions for Eye Care Professionals

4.5 Instructions for Patients

4.5.1 Handling precautions

4.5.2 Lens wearing precautions

4.5.3 Lens care precautions

4.5.4 Emergencies

4.5.5 Other topics to discuss with patients

4.5.6 Who should know that the patient is wearing

contact lenses?

5.0 Adverse Events

6.0 Device Description

6.1 Available Lens Parameters

6.2 Lens Properties

6.3 Oxygen Permeability

6.4 How Supplied

6.5 Theory of Operation

7.0 Instructions for Use

7.2 Preparation

7.2.1 General fitting guidelines

Pre-fitting examination

Initial Power Determination

7.2.2 Monovision fitting guidelines

Monovision needs assessment

Patient education

Eye selection

Unilateral vision correction requirement

Near ADD determination

7.3 Use

7.3.1 Base curve selection (trial lens fitting)

Criteria of a properly fit lens

Criteria of a flat fitting lens

Criteria of a steep fitting lens

7.3.2 Final lens power

7.3.3 Trial lens fitting – monovision

Adaptation

Other suggestions

7.4 After Use

7.4.1 Wearing schedule

7.4.2 Replacement schedule

7.4.3 Lens care directions

Basic instructions

Care for a sticking (non-moving) lens

7.4.4 Patient management

Dispensing visit

Follow-up examinations

Recommended follow-up examination

Recommended procedures for follow-up visits

12.0 Glossary

12.1 Symbols Key

13.0 Resources

Transmittance curves

Citations

1. Lerman, S., Radient Energy and the Eye, MacMillan, New York, 1980, p.58 figure 2-21

2. Waxler, M. Hitchins, V.M., Optical Radiation and Visual Health, CRC Press, Boca Raton, Florida, 1987, p.19, figure 5

3. New England Journal of Medicine, September 21, 1989, 321 (12), pp. 773-783

4. The CLAO Journal, July 1999, Volume 25, Number 3

14.0 Contact and Reporting Information

15.0 Date of Latest Revision