Section 22-B10319. USE OF IMPACT-RESISTANT LENSES IN EYEGLASSES AND SUNGLASSES

 

10319.1Examination 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.

 

10319.2The 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.

 

10319.3To 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.

 

10319.4The 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 § 10319.7.

 

10319.5Each 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 § 10319.7.  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 (1) 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 laminated glass lenses (such as lenses other than those described in the three (3) sentences of this paragraph), 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.

 

10319.6For the purpose of this regulation, the impact test described in § 10319.7 shall be the "referee test," defined as "one which will be utilized to determine compliance with a regulation."  The referee test provides the Department of Health 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 or any equal or superior test.  Whatever test is used, the lenses shall be capable of withstanding the impact test if the Department of Health examines them for performance.

 

10319.7In the impact test, a five-eighths inch (5/8 in.) steel ball weighing approximately 0.56 ounce is dropped from a height of fifty inches (50 in.) upon the horizontal upper surface of the lens. The ball shall strike within a five-eighths inch (5/8 in.) 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 four inches (4 in.) 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 (2) 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 one inch (1 in.) inside diameter, one and one quarter inch (1-1/4 in.) outside diameter, and approximately one inch (1 in.) 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 twenty-seven pounds (27 lbs.).  For lenses of small minimum diameter, a support tube having an outside diameter of less than one and one-fourth inches (1-1/4 in.) 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 one-eighth inch by one-eighth inch (1/8 in. x 1/8 in.) neoprene gasket having a hardness of 40 [+/-] 5, as determined by ASTM Method D 1415-88, Standard Test Method for Rubber Property -- International Hardness; a minimum tensile strength of one thousand two hundred pounds (1,200 lbs.), as determined by ASTM Method D 412-98A, "Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers-Tension;" and a minimum ultimate elongation of four hundred percent (400 %), as determined by ASTM Method D 412-68.  (Both methods are incorporated by reference and are 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. NW., Suite 700, Washington, DC.)  The diameter or contour of the lens support may be modified as necessary so that the one-eighth inch by one-eighth inch (1/8 in. x 1/8 in.) neoprene gasket supports the lens at its periphery.

 

10319.8Copies 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 three (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 section shall be made available upon request at all reasonable hours to any officer or employee of the Department of Health 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.

 

10319.9In addition, those persons conducting tests in accordance with §§ 10319.6 and 10319.7 shall maintain the results thereof and a description of the test method and of the test apparatus for a period of three (3) years.  These records shall be made available upon request at any reasonable hour by any officer or employee acting on behalf of the Department. 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.

 

10319.10For the purpose of this section, the term "manufacturer" includes an importer for resale.  Such importer may have the tests conducted in the country of origin but must make the results thereof available, upon request, to the Department, as soon as practicable.

 

10319.11All lenses shall be impact-resistant except when the physician or optometrist finds that impact-resistant lenses will not fulfill the visual requirements for a particular patient.

 

10319.12This statement of policy shall not apply to contact lenses.

 

 

authority

Section 19(a)(3) of the District of Columbia Pharmacist and Pharmacy Regulation Act of 1980, effective September 16, 1980 (D.C. Law 3-98; D.C. Official Code § 47-2885.18(a)(3) (2005 Repl.)); Mayor’s Order 98-48, dated April 15, 1998; Section 4902 of the Fiscal Year 2002 Budget Support Act of 2001, effective October 3, 2001 (D.C. Law 14-28; D.C. Official Code § 7-731 (2008 Repl.)); Section 15 of the District of Columbia Medical Device Manufacture and Distribution Licensure Act of 1990, effective June 13, 1990 (D.C. Law 8-137; D.C. Official Code § 48-714(a) (2005 Repl.)); and Mayor’s Order 98-88, dated May 29, 1998.

source

Final Rulemaking published at 60 DCR 10252 (July 12, 2013).