Who should perform the test for impact resistance?
A. The manufacturer must perform the test for impact resistance (21 CFR 801.410(d)(1)). Manufacturer is defined under 21 CFR 820.3(o) and would include the person (or firm) who puts the lens in the form ready for its intended use or who alters the physical or chemical characteristics of the lens by grinding, heat treating, beveling, applying scratch resistant coating, applying anti-reflection coating, cutting, or other pertinent actions. Manufactures of all plastic lenses and non-prescription glass lenses may test at the uncut-finished or finished stage while glass prescription lenses must be tested at the finished stage. Retail laboratories that perform some or all of these processes are manufacturers. For the purpose of 21 CFR 801.410, the term “manufacturer” also includes a company that imports impact resistant lenses for eyeglasses, or who imports finished eyeglasses or sunglasses for resale. (21 CFR 801.410(g)) 21. Q. When should lenses be tested for impact resistance? A. You shou
