Health Care Professionals Participating at FDA

Survey of Health Care Practitioners for Device Labeling Format and Content

Attachment G--Sample Labeling current mfr TOC Only Acuvue

Health Care Professionals Participating at FDA

OMB: 0910-0790

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TABLE OF CONTENTS

  1. Symbols Key

  2. Description

2.1 Lens Properties

2.2 Oxygen Permeability

3. Available Lens Parameters

3.1 Diameter

3.2 Center Thickness

3.3 Base Curve

3.4 Power Range

4. Transmittance Curves

4.1Warning about UV Absorption

5. Actions

5.1 Note about UV Radiation Exposure

6. Indications (Uses)

7. Contraindications (Reasons Not to Use)

8. Warnings

8.1 Eye Problems leading to Vision Loss

8.2 Specific Instructions for Use and Warnings

8.2.1 Water activity

9. Precautions

9.1 Special Precautions for Eye Care Professionals

9.2 Instructions for Patients

9.2.1 Handling precautions

9.2.2 Lens wearing precautions

9.2.3 Lens care precautions

9.2.4 Other topics to discuss with patients

Who should know that the patient is wearing contact lenses?

10. Adverse Reactions

11. General Fitting Guidelines

11.1 Patient Selection

11.2 Pre-fitting Examination

11.3 Initial Power Determination

11.4 Base Curve Selection (Trial Lens Fitting)

11.4.1 Criteria of a properly fit lens

11.4.2 Criteria of a flat fitting lens

11.4.3 Criteria of a steep fitting lens

11.5 Final Lens Power

12. Monovision Fitting Guidelines

12.1 Patient Selection

12.1.1 Monovision needs assessment

12.1.2 Patient education

12.2 Eye Selection

12.2.1 Ocular preference determination methods

12.2.2 Refractive error method

12.2.3 Visual demands method

12.3 Special Fitting Characteristics

12.3.1 Unilateral vision correction requirement

12.3.2 Near ADD determination

12.3.3 Trial lens fitting

12.3.4 Adaptation

12.3.5 Other suggestions

13. Patient Management

13.1 Dispensing Visit

13.2 Follow-up examinations

13.2.1 Recommended follow-up examination

13.2.2 Recommended procedures for follow-up visits

14. Wearing Schedule

15. Replacement Schedule

16. Lens Care Directions

16.1 Basic Instructions

16.2 Care for a Sticking (Non-Moving) Lens

17. Emergencies

18. How Supplied

19. Reporting of Adverse Reactions

18.1 Manufacturer Name

18.2 Manufacturer Address

18.3 Telephone number

18.4 Website URL

20. Bar Code

21. Manufacturer Information

20.1 Where printed

20.2 Revision Date

20.3 Revision Number



File Typeapplication/vnd.openxmlformats-officedocument.wordprocessingml.document
AuthorNancy Ostrove
File Modified0000-00-00
File Created2021-01-25

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