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
| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| Author | Nancy Ostrove |
| File Modified | 0000-00-00 |
| File Created | 2021-01-25 |