What are the impact testing requirements for prescription (Rx) glass lenses?
A. The manufacturer must test each finished Rx glass lens individually for impact resistance (21 CFR 801.410(c)(3)). The lens must be capable of withstanding the impact test provided in 21 CFR 801.410(d)(2) as described under “Testing Apparatus and Procedure” below. You should perform testing after the lens has been edged (cut to the shape of the frame) but before the lens is put into the frame. 2. Q. What are the impact testing requirements for non-prescription (over-the-counter) glass lenses, e.g., magnifying spectacles and nonprescription sunglasses? Magnifying spectacles are intended to be worn by a patient who has impaired vision to enlarge images. See 21 CFR 886.5840. Nonprescription sunglasses are intended to be worn to protect the eyes from bright sunlight but not to provide refractive corrections. See 21 CFR 886.5850. A. Under 21 CFR 801.410(c)(3), you must test a statistically significant sample of over-the-counter glass lenses from each production batch. The sample must be r
