Standards for Ophthalmic Lenses

What are the main players for regulating ophthalmic prescriptions and lenses.

• Food & Drug Administration (FDA)

• Federal Trade Commission (FTC)

• Occupational Safety & Health Administration (OSHA)

• American National Standards Institute (ANSI)

• Optical Laboratories Association (OLA)

What does the FDA regulate?

Requiring impact resistance for spectacle lenses in 1972. Found nontempered crown glass lenses were a “avoidable hazard” to the wearer due to shattering

How can glass be tempered?

• Thermal tempering

• Chemical tempering

How is impact resistance tested?

Drop ball test.

What are the drop ball requirements for dress eyewear?

• 5/8 inch steel ball

• Weight 0.56 ounces

• 50 inches drop height

• Dropped onto geometric center of front surface of lens

• Lenses must be tested individually (with some exception)

What are the drop ball requirements for safety eyewear?

• 1 inch steel ball

• Weight 2.4 ounces

• 50 inches drop height

• Dropped onto geometric center of front surface of lens

What are the exceptions for the drop ball test on every lens?

• Raised edge multifocals

• Laminated glass lenses

• prism segments

• slab-off

• lenticular aphakic

• eikonic

• depressed segment one piece multifocals

• myodisc, biconcave, minus lenticular, cemented lenses

For lenses that cannot be individually tested, what is done instead?

Batch testing. If the sample fails, the entire batch is thrown. If the sample passes, the entire batch can be used.

Are there minimum thickness requirements for dress eyewear?

No, just needs to pass shatter resistance.

What does the Federal Trade Commission do?

Promulgates rules regulating commerce to prevent unfair business practices for consumer protection

What does the FTC’s Eyeglasses I (1978) do?

Ensures every patient is given a copy of their spectacle prescription at the end of the eye exam.

• Even if they do not request it

• Even if there is no Rx change

• Even if the Rx change is minimal and new specs are not indicated

• Even if they have not paid for the exam (changed later)

What does Eyeglasses I require to be given on the printed copy of the spec prescription?

• Sphere power

• Cyl power

• Prism

• Signature of prescribing doctor

• Prohibits disclaimers/coercive language

What does the FTC’s Eyeglass II (1989) require?

• Remove requirement of minimum info on Rx

• Suggests expiration date

• Prohibition of third party disclaimers continues

• Does not require release of CL Rx (newer rules do)

• 2024: Pt signature required indicating received Rx