국내 유통 NK55 재질 안경렌즈의 내충격 시험 평가

Purpose: The present study was performed to evaluate the safety of ophthalmic lenses in domestic market since eyeglasses wearers could be exposed to the negligent accident by damaged ophthalmic lenses. Method: Totally, 160 ophthalmic lenses (NK55, nd = 1.56) with the refractive powers of -3D, -6D, +3D, +6D manufactured by 4 companies in domestic market were evaluated using drop ball test. In accordance with FDA standard, steel ball (~16 g) was freely dropped on these ophthalmic lenses from 127 cm high and the surfaces of lenses were observed. Results: From the study, center thicknesses of NK55 ophthalmic lenses manufactured by 4 different companies showed somewhat different numbers even though the lenses had the same refractive index and powers. All convex lenses of +3D, +6D were evaluated as the safe lenses since there was no damage such as crack and broken found on the lens surfaces after drop ball testing. However, some noticeable broken was shown on the surfaces of concave lenses with relatively thinner center thickness. Especially, 59(73.8%) of total 80 concave lenses with the refractive power of -3D and -6D classified as unacceptable lenses to FDA standard. Conclusions: From the results, the negligent accident by damaged ophthalmic lenses should be considered as well as the correction of visual acuity, design and price when customers purchase eyeglasses. Thus, the enforcement regulation like drop ball testing of uncut ophthalmic lens could be suggested to guarantee the safety of ophthalmic lenses in domestic market.