市售軟性隱形眼鏡光度及含水量之品質調查

An Inspection on Powers and Water Content of Soft Contact Lenses in Taiwan Area

10.6946/ASRNL.200309.0044

蔡瑜瑩(Yu-Ying Tsai)；吳正寧(Cheng-Ning Wu)；杜培文(Pei-Weng Tu)；黃明權(Ming-Chuan Huang)

隱形眼鏡 ； 含水量 ； 光度 ； contact lenses ； water contact ； power

藥物食品檢驗局調查研究年報

21號（2003 / 09 / 01）

44 - 50

繁體中文

為了解市售軟性隱形眼鏡之品質，本局委請各縣市衛生局於民國九十一年五月至六月至轄區軟式隱形眼鏡製造廠及代理商處抽驗軟性隱形眼鏡，共計41件。經參照廠商原申請查驗登記時檢附之檢驗規格及方法，進行外觀、光度及含水量試驗。測試結果，不合格者1件，佔總件數之2.4%。不合格之檢體為輸入品，含水量試驗不合格，顯示經衛生署查驗登記許可之軟性隱形眼鏡其品質尚可。有關產品標示部分則有8件檢體不符合藥事法之規定，佔總件數之19.5%。本調查係本局之比較檢驗，曾於九十一年十一月十五日發佈新聞在案。

Recently, consumers in Taiwan prefer to wear soft contact lenses for beauty and convenience purposes. There are many brands of contact lenses on the market. Since these products contact cornea directly, their quality will influence health and safety of eye. In Taiwan, contact lenses is one kind of the medical devices which requires pre-market approval from Department of Health (DOH). Due to the difficulties in sampling enough quantities contact lenses of the same lot number, studies related to the eyeglasses store on the qualities were never been conducted. Starting this year, the local health authorities were designated to carry out the sampling from manufacturers, importers and eyeglasses stores The sampled products were tested for the appearance, power and water content. The results indicated that one test sample (2.4%), which was imported from Korea, did not comply with its specification on water content. Eight samples (19.5%) failed to meet the regulation requirements on labeling.