Thu, Aug 29, 2024 page1

• FDA issues recall for 11 batches of contact lenses

  • By Lee I-chia / Staff reporter
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  The Food and Drug Administration (FDA) on Tuesday last week issued a recall for 11 batches, 306 boxes in total, of two types of contact lenses by Alcon Inc, due to a quality issue that might cause eye irritation, red eyes or blurred vision.

  The two types of contact lenses are Dailies Total1 One-Day Contact Lenses for Astigmatism, with the batch numbers N1276094, N1275909 and N1275914; and Dailies Total1 One-Day Contact Lenses Multifocal, with the batch numbers N1275753, N1276198, N1276224, N1276237, N1276203, N1277330, N1276304 and N1275728.

  Alcon recently identified an isolated quality issue with a solvent supplied by a third-party vendor that was used in manufacturing specific lots of the contact lenses, the FDA said.

  

  Shelfs of contact lens are pictured yesterday.

  Photo: Chiu Chih-jo, Taipei Times

  The identified lots might not meet Alcon’s performance standards for the entirety of their shelf life, so the company initiated a voluntary recall, it said.

  The quality issue is not expected to cause a safety risk to people, but they might have temporary symptoms, such as eye irritation, red eyes or blurred vision, it said, adding that wearers should remove the lenses if such symptoms occur.

  FDA Deputy Director-General Wang Der-yuan (王德原) yesterday said Taiwan is a major manufacturer of contact lenses, with annual sales exceeding US$500 million, marking the highest export value among medical devices made in the nation.

  There are 34 registered local manufacturers and 51 importers of contact lenses, and the FDA has issued about 1,400 permits for such products, he said.

  Wang said 1,163 of those products are made in Taiwan and more than 600 are circle lenses (also known as a big eye-contacts).

  The government classifies contact lenses as medical devices, and according to the Medical Devices Act (醫療器材管理法), the entire manufacturing process, from material to packing, must comply with the quality management system standards, he said.

  As medical devices, contact lenses cannot be sold online, he said.

  The FDA advises consumers to carefully check the product information and medical device permit number on their package before purchasing them from a legal and credible supplier, he added.

  Taipei Medical University Hospital ophthalmologist Lin I-hung (林宜鴻) yesterday said the most common types of soft contact lenses are made of hydrogel or silicone hydrogel materials, which are quite different.

  Hydrogel lenses are cheaper, flexible and feel soft and comfortable on the eyes due to their higher water content, but as water gradually evaporates, they could get drier and feel less comfortable, he said.

  Silicone hydrogel lenses have less water content, but higher oxygen permeability levels, so they could be a healthier option for the cornea if worn for longer periods, he said.

  Hydrogel lenses could be a better option for people who have sensitive eyes or who wear them for shorter periods, such as when exercising, he said.

  On the other hand, silicone hydrogel lenses could be better for office workers who look at computer screens for long hours, he said.

  However, none of them should be worn for more than eight hours at a time, he said.
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