市售彩色隱形眼鏡之色素溶出物試驗品質監測   全文下載

Color Additive Survey of Daily Wear Contact Lenses Available in Taiwan’s Market

隱形眼鏡是直接配戴在角膜及眼睛鄰近邊緣區或鞏膜區，用來矯正視力或作為治療用繃帶的器材。日本國民生活中心曾針對市售的彩色瞳孔放大片進行安全性檢測，發現部分產品讓配戴者出現眼角膜、結膜受傷情況，為確保消費者使用彩色隱形眼鏡的安全，擬進行色素溶出物之品質監測。於105年1月至6月間，委由各縣市衛生局赴轄區內眼鏡行、藥粧店、醫療器材行、製造廠、藥局等地進行市售產品之抽驗，抽得拋棄式彩色隱形眼鏡產品共28件，其中國產品22件，輸入品6件。參考國際公定標準及各產品查驗登記規格進行彩色隱形眼鏡色素溶出物檢驗。結果顯示28件檢體均未檢出色素溶出物。

Contact lenses were worn directly on the cornea and the sclera for vision correction. The market surveillance report of the coloered contact lens with pupil dilation effect published by the National Consumer Affairs Center of Japen identified some producted that caused injuried of cornea and conjunctivea. In order to protect the consumers in Taiwan from such injuries, a survey of daily wear contact lenses was conducted. In 2016, from January to June, our local health authorities collected 28 samples from hospitals, clinics, pharmacies and factories all over Taiwan. Amoung them, 22 were made in China and 6 were imported somewhere else. The color additives were the main concern of this survey and the sample lens extractions were tested for color additives according to the published international methods and stardards. In the extracts of these 28 samples, there was no detectable presence of the color additives. This finding has been forwarded to the local health authorities as references.