According to the State Food and Drug Administration issued “on decorative colored flat contact lenses in accordance with the medical device management announcement”, decorative colored flat contact lenses (contacts) as a higher-risk medical device products, has been included in the three types of medical devices regulatory category, April 1, without a medical device registration certificate units may not produce and sell such products. Violation of the provisions of the food and drug supervision and management departments will be investigated and punished according to law. The city’s Drug Administration received a number of complaints last year The pupil was originally introduced by Johnson & Johnson colored contact lenses, because it entered the beauty lens market in China earlier, plus the name is easy to remember, now “pupil” has become a generic term for colored flat contact lenses (Note: this article refers to the “pupil (Note: The “contacts” in this article also refer to colored flat contact lenses in general, not specifically to Johnson & Johnson contacts). Contact lenses were incorporated into the medical device management category as early as 2005, and units that did not obtain a medical device registration certificate were not allowed to sell them. But for the later emergence of color flat contact lenses for cosmetic purposes, how to manage the domestic drug regulatory system is also divided. One opinion is that it belongs to the category of contact lenses, according to the management of medical devices. Another opinion is that “contacts” for cosmetic use do not have a prescription and do not meet the definition of a medical device and cannot be managed as such. Due to the growing number of wearers and the lack of regulation, there have been more and more complaints and problems, and last year, the Hangzhou Drug Administration received nearly 100 complaints about adverse contact lens events, many of which were from contact lens wearers. Due to the lack of clear regulations, even if stores are found to be selling contacts with questionable product quality, our drug regulators can only persuade them to take them off the shelves and cannot deal with them, and the regulatory effort is greatly reduced. Earlier this year, the domestic drug regulatory authorities finally reached a consensus to include “contacts” in the management of medical devices, which means that from April 1, the production and sale of “contacts” products are subject to a licensing system; non-compliant operators will be confiscated illegal income This means that from April 1, the production and sale of “beauty” products are subject to a licensing system; operators who violate the law will have their illegal income confiscated and be fined more than 5,000 yuan. The so-called imported “contacts” in small stores are mostly copycat goods produced in Jiangsu and Taizhou. Some small cosmetic stores and night markets in Hangzhou used to sell “contacts”, most of which claimed to be imported from the United States, Japan and Korea, without Chinese labels. A store owner in Wushan night market admitted that these so-called imported “contacts” are in fact basically cottage goods, generally from Jiangsu or Taizhou, or from the Internet, the lowest purchase price of only 5 yuan per piece. What is the difference between these cottage goods and regular “contacts” products? The regular colored contact lenses, whether flat or prescription, are a sandwich layer structure, the dye is located in the middle layer, not in direct contact with the eyes, and will not leak, and the dye permeability also needs to meet the basic standards of contact lenses; while many of the three no “contacts” products, some are directly in the lens inside or outside The coloring of some of these products is directly on the inside or outside of the lens, and some of them are colored in the interlayer, but there is a risk of leakage and the oxygen permeability is not up to standard, and the coloring of some poor quality products will even fade when soaked in tears. This kind of lenses will certainly produce allergic, immune and other inflammatory stimuli on the eye surface, resulting in bacterial keratitis and corneal roughness, and even bleeding in serious cases, which has been encountered in many clinical cases; in addition, it should be reminded that even if the regular manufacturers of ‘contacts’ tablets, their resistance to protein and oxygen permeability compared to ordinary colorless The contact lenses are not recommended for long-term wear. In March 2010, a girl in her 20s went to Zhejiang Eye Hospital (Wenzhou Medical College Affiliated Optometric Hospital) to have one of her eyes treated with imported cottage “contacts” for two years. She had been wearing imported “contacts” for two years and had a serious corneal infection, with the center of the visual axis above the pupil covered by white spots. The white spots were large and located right in the center of the eye covering the pupil, and could not be removed after conventional treatment. She was fortunate to have a suitable corneal donor and a corneal transplant to restore her vision after two months of waiting. In outpatient clinics, 50 percent of contact lens wearers with serious eye problems are “pupil” wearers, some with corneal perforations, some with excessive neovascularization of the cornea, and some with corneal white spots, all of which carry the risk of blindness. Does it matter if I wear them for a short period of time? From our clinical point of view, the duration of wear is not directly proportional to the severity of the eye disease, but can have serious consequences if any of the links are faulty. These links include: 1) the quality of the lenses; 2) the hygiene habits when wearing them, whether they are cleaned daily, whether they are disinfected with boiling water regularly, and whether the cases are replaced every three months; 3) whether the eyes are seen in a timely manner for discomfort. The first thing you need to do is to go to a hospital or a major optician to buy “contacts” and go to an optician or hospital with a medical device license. First, color contact lenses are confirmed to be a Class III medical device, which means that they must be managed according to the highest level of regulation, and not all opticians are qualified to sell them. If consumers find that they can also report to the FDA; second, not everyone is suitable for contact lenses, such as keratitis, conjunctivitis, trachoma, dacryocystitis, dry eye disease patients are not allowed to wear, buy in the hospital can get a more professional scientific examination and optometry. To wear contact lenses, you must measure the basal arc, which is an index of the amplitude of the eye. The base arc determines the ‘size’ of the contact lens that needs to be fitted. If your cornea is flat and you choose a contact lens that is too tight without measurement, your eyes will be prone to oxygen deprivation and eye redness; on the contrary, if the cornea is steeper and the lens is flatter, it will cause the lens to move too much and you will have a foreign body feeling when wearing it, and many opticians will Ignore this point. The most important thing to know is whether or not to buy “contacts” products are qualified products, the most important point is to see whether or not the product label is marked with the words “National Pharmaceutical Machinery Quasi-Zi × × No.” If not, or if it is in a foreign language, it is not approved by the Drug Administration and is an illegal product.