[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR801.410]

[Page 24-26]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES--(Continued)
 
PART 801--LABELING--Table of Contents
 
          Subpart H--Special Requirements for Specific Devices
 
Sec. 801.410  Use of impact-resistant lenses in eyeglasses and sunglasses.

    (a) Examination of data available on the frequency of eye injuries 
resulting from the shattering of ordinary crown glass lenses indicates 
that the use of such lenses constitutes an avoidable hazard to the eye 
of the wearer.
    (b) The consensus of the ophthalmic community is that the number of 
eye injuries would be substantially reduced by the use in eyeglasses and 
sunglasses of impact-resistant lenses.
    (c)(1) To protect the public more adequately from potential eye 
injury, eyeglasses and sunglasses must be fitted with impact-resistant 
lenses, except in those cases where the physician or optometrist finds 
that such lenses will not fulfill the visual requirements of the 
particular patient, directs in writing the use of other lenses, and 
gives written notification thereof to the patient.
    (2) The physician or optometrist shall have the option of ordering 
glass lenses, plastic lenses, or laminated glass lenses made impact 
resistant by any method; however, all such lenses shall be capable of 
withstanding the impact test described in paragraph (d)(2) of this 
section.
    (3) Each finished impact-resistant glass lens for prescription use 
shall be individually tested for impact resistance and shall be capable 
of withstanding the impact test described in paragraph (d)(2) of this 
section. Raised multifocal lenses shall be impact resistant but need not 
be tested beyond initial design testing. Prism segment multifocal, slab-
off prism, lenticular cataract, iseikonic, depressed segment one-piece 
multifocal, bioconcave, myodisc and minus lenticular, custom laminate 
and cemented assembly lenses shall be impact resistant but need not be 
subjected to impact testing. To demonstrate that all other types of 
impact-resistant lenses, including impact-resistant laminated

[[Page 25]]

glass lenses (i.e., lenses other than those described in the three 
preceding sentences of this paragraph (c)(3)), are capable of 
withstanding the impact test described in this regulation, the 
manufacturer of these lenses shall subject to an impact test a 
statistically significant sampling of lenses from each production batch, 
and the lenses so tested shall be representative of the finished forms 
as worn by the wearer, including finished forms that are of minimal lens 
thickness and have been subjected to any treatment used to impart impact 
resistance. All nonprescription lenses and plastic prescription lenses 
tested on the basis of statistical significance shall be tested in 
uncut-finished or finished form.
    (d)(1) For the purpose of this regulation, the impact test described 
in paragraph (d)(2) of this section shall be the ``referee test,'' 
defined as ``one which will be utilized to determine compliance with a 
regulation.'' The referee test provides the Food and Drug Administration 
with the means of examining a medical device for performance and does 
not inhibit the manufacturer from using equal or superior test methods. 
A lens manufacturer shall conduct tests of lenses using the impact test 
described in paragraph (d)(2) of this section or any equal or superior 
test. Whatever test is used, the lenses shall be capable of withstanding 
the impact test described in paragraph (d)(2) of this section if the 
Food and Drug Administration examines them for performance.
    (2) In the impact test, a \5/8\-inch steel ball weighing 
approximately 0.56 ounce is dropped from a height of 50 inches upon the 
horizontal upper surface of the lens. The ball shall strike within a \5/
8\-inch diameter circle located at the geometric center of the lens. The 
ball may be guided but not restricted in its fall by being dropped 
through a tube extending to within approximately 4 inches of the lens. 
To pass the test, the lens must not fracture; for the purpose of this 
section, a lens will be considered to have fractured if it cracks 
through its entire thickness, including a laminar layer, if any, and 
across a complete diameter into two or more separate pieces, or if any 
lens material visible to the naked eyes becomes detached from the ocular 
surface. The test shall be conducted with the lens supported by a tube 
(1-inch inside diameter, 1\1/4\-inch outside diameter, and approximately 
1-inch high) affixed to a rigid iron or steel base plate. The total 
weight of the base plate and its rigidly attached fixtures shall be not 
less than 27 pounds. For lenses of small minimum diameter, a support 
tube having an outside diameter of less than 1\1/4\ inches may be used. 
The support tube shall be made of rigid acrylic plastic, steel, or other 
suitable substance and shall have securely bonded on the top edge a \1/
8\- by \1/8\-inch neoprene gasket having a hardness of 
40plus-minus5, as determined by ASTM Method D 1415-88, 
``Standard Test Method for Rubber Property--International Hardness'' a 
minimum tensile strength of 1,200 pounds, as determined by ASTM Method D 
412-98A, `Standard Test Methods for Vulcanized Rubber and Thermoplastic 
Elastomers--Tension, and a minimum ultimate elongation of 400 percent, 
as determined by ASTM Method D 412-68 (Both methods are incorporated by 
reference and are available from the American Society for Testing 
Materials, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 
19428, or available for inspection at the Center for Devices and 
Radiological Health's Library, 9200 Corporate Blvd., Rockville, MD 
20850, or at the Office of the Federal Register, 800 North Capitol St., 
N.W., suite 700, Washington, DC. The diameter or contour of the lens 
support may be modified as necessary so that the \1/8\- by \1/8\-inch 
neoprene gasket supports the lens at its periphery.
    (e) Copies of invoice(s), shipping document(s), and records of sale 
or distribution of all impact resistant lenses, including finished 
eyeglasses and sunglasses, shall be kept and maintained for a period of 
3 years; however, the names and addresses of individuals purchasing 
nonprescription eyeglasses and sunglasses at the retail level need not 
be kept and maintained by the retailer. The records kept in compliance 
with this paragraph shall be made available upon request at all 
reasonable hours by any officer or employee of the Food and Drug 
Administration or by any other officer or employee acting on behalf of 
the Secretary of Health and

[[Page 26]]

Human Services and such officer or employee shall be permitted to 
inspect and copy such records, to make such inventories of stock as he 
deems necessary, and otherwise to check the correctness of such 
inventories.
    (f) In addition, those persons conducting tests in accordance with 
paragraph (d) of this section shall maintain the results thereof and a 
description of the test method and of the test apparatus for a period of 
3 years. These records shall be made available upon request at any 
reasonable hour by any officer or employee acting on behalf of the 
Secretary of Health and Human Services. The persons conducting tests 
shall permit the officer or employee to inspect and copy the records, to 
make such inventories of stock as the officer or employee deems 
necessary, and otherwise to check the correctness of the inventories.
    (g) For the purpose of this section, the term ``manufacturer'' 
includes an importer for resale. Such importer may have the tests 
required by paragraph (d) of this section conducted in the country of 
origin but must make the results thereof available, upon request, to the 
Food and Drug Administration, as soon as practicable.
    (h) All lenses must be impact-resistant except when the physician or 
optometrist finds that impact-resistant lenses will not fulfill the 
visual requirements for a particular patient.
    (i) This statement of policy does not apply to contact lenses.

[41 FR 6896, Feb. 13, 1976, as amended at 44 FR 20678, Apr. 6, 1979; 47 
FR 9397, Mar. 5, 1982; 65 FR 3586, Jan. 24, 2000; 65 FR 44436, July 18, 
2000]