Ординатура / Офтальмология / Английские материалы / Essentials of Ophthalmic Lens Finishing, 2nd edition_Brooks_2003

Vertical Prism

For lenses of ±3.375 D or below in the vertical meridian For lenses stronger than ±3.375 D in the vertical meridian

Unwanted vertical imbalance shall not exceed 0.33

The vertical differences between prism reference points may not be greater than 1.0 mm

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TABLE B-8

A P P E N D I X B A N S I Z 8 0 . 1 P R E S C R I P T I O N O P H T H A L M I C L E N S E S — R E C O M M E N D AT I O N S

Determining whether Refractive Power is within Tolerance

The following text outlines a cookbook method that may be used to see if the refractive power of a prescription is within ANSI standards.

EXAMPLE B-2

Following is an example of a prescription where the meridian of highest absolute power is not the sphere power. Determine whether or not the prescription passes ANSI refractive power tolerances.

The material in this appendix has been reproduced from the following federal publication:

Code of Federal Regulations

Title 21, Volume 8, Parts 800 to 1299 Revised as of April 1, 2000

From the U.S. Government Printing Office via GPO Access

Cite: 21CFR801.410 Pages 24-26

Title 21—Food and Drugs 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, bi-concave, 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 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.

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(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.

5

(2) In the impact test, a – -inch steel ball weighing

8

approximately 0.56 ounce is dropped from a height of 50 inches upon the horizontal upper surface of the

5

lens. The ball shall strike within a – -inch diameter circle

8

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

(1-inch inside diameter, 1– -inch outside diameter, and

4

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

1

support tube having an outside diameter of less than 1–

4

inches may be used. The support tube shall be made of rigid acrylic plastic, steel, or other suitable substance

1

and shall have securely bonded on the top edge a 1– - by

8

1

1– -inch neoprene gasket having a hardness of 40 ± 5 as

8

determined by ASTM Method D 1415-88, “Standard Test Method for Rubber Property—International Hardness” a minimum tensile strength of 1200 pounds, as determined by ASTM Method D 412-97, Standard Test Methods for Vulcanized Rubber and Thermoplastic Rubbers 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 10850, or

A P P E N D I X C F D A P O L I C Y

at the Office of the Federal Register, 800 North Capitol St., NW, Suite 700, Washington, DC.) The diameter or contour of the lens support may be modified as

1 1

necessary so that the 1– - by 1– -inch neoprene gasket

8 8

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 Human Services and such officer or employee shall be permitted to inspect and copy such records, to make such inventories of stock as he [or she] 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]

Effective Date Note: At 65 FR 3586, Jan. 24, 2000, Secs. 801.410 was amended in paragraph (d)(2) by removing “ASTM Method D 1415-68 Test for International Hardness of Vulcanized Rubber,” and adding in its place “ASTM

Method D 1415-88, Standard Test Method for Rubber Property— International Hardness”; by removing “ASTM Method D 412-68 Tension Test of Vulcanized Rubber,” and adding in its place “ASTM Method D 412-97, Standard Test Methods for Vulcanized Rubber and Thermoplastic Rubbers and Thermoplastic Elastomers—Tension”; and by removing “1916 Race St., Philadelphia, PA 19103, or available for inspection at the Office of the Federal

Register, 800 North Capitol Street, NW, Suite 700, Washington, DC 20408” and adding in its place “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 10850, or at the Office of the Federal Register, 800 North Capitol St., NW, Suite 700, Washington, DC,” effective June 7, 2000.

@Symbol for at, or in the same meridian as.

A

A The horizontal dimension of the boxing system rectangle that encloses a lens or lens opening.

Abbé value See value, Abbé.

aberration The resulting degradation of an image that occurs when a point source of light does not result in a single-point image after going through the lens or lens system.

aberration, chromatic The type of aberration that causes light of different wavelengths (colors) to be refracted differently through the same optical system. aberration, lateral chromatic An aberration that produces images of slightly different sizes at the focal length of the lens, depending upon the color of the

light. (Synonym: chromatic power.)

aberration, longitudinal chromatic Occurs when a point light source that is composed of several wavelengths (like white light) forms a series of point images along the optical axis. Each of these images is a different color and each has a slightly different focal length.

aberration, monochromatic An aberration that is present even when light is made up of only one wavelength (one color).

aberration, spherical An aberration that occurs when parallel light from an object enters a large area of a spherical lens surface and peripheral rays focus at different points on the optic axis than do paraxial rays.

absolute refractive index See index, absolute refractive. accurate sag formula See formula, accurate sag. actual power See power, actual.

add See addition, near.

add, nasal The modification of an existing lens shape by allowing more lens material to remain in the inferior, nasal position than would be indicated otherwise for the purpose of creating a better frame fit.

addition, near The power that a lens segment has in addition to that power already present in the main portion of the lens.

alignment, horizontal A lack of deviation of the two datum lines in a pair of spectacles from a single horizontal plane (neither lens higher than the other when viewed from the front).

alignment, standard An impersonal standard, independent of facial shape, for the alignment of spectacle frames.

G L O S S A R Y

alignment, vertical Lack of deviation of the two spectacle lenses from the vertical plane (one being neither further forward nor backward than the other).

allowance, grinding Synonym for wheel differential. allowance, vertex power The amount by which the

front surface curvature of a lens must be flattened to compensate for a thickness-related gain in power.

American endpiece See endpiece, American.

American National Standards Institute An industrybased, nongovernmental standards-setting association. The American National Standards Institute is an agency that addresses standards throughout all of industry, of which the ophthalmic industry is only a small part. ANSI sets standards for aspects of the ophthalmic industry that includes lenses, frames, and contact lenses.

Amethyst Contrast Enhancer (ACE) A selectively absorbing glass developed by Schott that is said to enhance contrast and be advantageous for target and trap shooting, hunting, computer terminal viewing, skiing, and bird watching. The lens allows highest transmission around the blue, green, and red regions of the spectrum.

A trade name for an automated

The difference between the angle of incidence and the angle of refraction.

angle, apical The angle formed by the junction of two nonparallel prism surfaces.

angle, crest The angle from the tip to the top of the nose (between the eyes) compared with a vertical plane roughly parallel to the brows and cheeks.

angle, effective diameter The angle from the 0- degree side of the 180-degree line to the axis of the effective diameter. The angle is referred to by the letter X and is measured using the right lens.

angle, frontal 1. The angle with which each side of the nose deviates from the vertical. 2. The angular amount the nosepad face deviates from the vertical when the frame is viewed from the front.

angle, pantoscopic 1. In standard alignment that angle by which the frame front deviates from the vertical (lower rims farther inward than upper rims) when the spectacles are held with the temples horizontal. 2. In fitting, that angle that the frame front makes with the frontal plane of the wearer’s face when the lower rims are closer to the face than the upper rims (oppositeretroscopic angle). (Synonym: pantoscopic tilt.)

angle, retroscopic That angle that the frame front makes with the frontal plane of the wearer’s face when the lower rims are farther from the face than the upper rims (opposite-pantoscopic angle). (Synonym: retroscopic tilt.)