CFDA sampling: 14 medical devices failed

Pharmaceutical Network Dec. 19 hearing to strengthen the quality supervision and management of medical devices to ensure safe and effective use of medical device products, the State Food and Drug Administration organized a soft touch lens 188 batches of a batch of 188 products quality supervision sampling. Sampling results announcement is as follows:

First, the sampling of medical devices that do not meet the standard requirements involves 14 batches of 9 enterprises, which are:

Soft contact lens 14 companies in 14 batches of products. Yu Jia Technology Co., Ltd. produced a batch of sweet new love soft hydrophilic contact lenses, 1 batch crystal soft hydrophilic contact lenses, base radius of arc or Given the bottom diameter of the arrow height does not meet the standard requirements; Jiangsu John Long Optical Co., Ltd. produced a batch of soft hydrophilic contact lenses, oxygen permeability does not meet the standard requirements; South Korea GEO Medical Co., Ltd produced a batch of soft Hydrophilic Contact Lenses Soft Contact Lens (proxy Person: Shanghai Gao Lebo glasses Co., Ltd.), the total diameter, base radius of curvature or a given bottom diameter of the high angle does not meet the standard requirements; Guangzhou Qi Anqi Vision Technology Co., Ltd., (Taiwan) Fine Optical Co., Ltd., Shanghai Wei Kang optical glasses Co., Ltd. produced a batch of soft hydrophilic contact lenses, the total diameter does not meet the standards; Qingdao New Haiba Optoelectronics Co., Ltd. produced three batches of soft hydrophilic contact lenses, the total diameter does not meet Standard, which, after 1 batch of vertex does not meet the standard requirements; Jing Shuo Optical Co., Ltd. produced two batches, Yongsheng Optical Co., Ltd. produced two batches of soft hydrophilic contact lenses, ultraviolet light Requirements (when applicable) does not meet the standard requirements.

The above sampling does not meet the standard requirements of the specific circumstances of the product, see Annex 1.

Second, the sampling project all in line with the provisions of the standard medical instruments 67 products involved enterprise 174 batches of 1 species, see Annex 2.

Third, the relevant enterprises should carry out risk assessment of the products that fail to meet the standard requirements, determine the recall level according to the severity of medical device defects, take the initiative to recall the product and publicly recall the information, and at the same time, identify the cause of the product failure and formulate corrective measures Rectification and reform in place on time, the disposal of the situation in January 6, 2018 to the public, and promptly report the relevant circumstances to the provincial food drug Supervision and administration department.

Fourth, the sampling found in the product does not meet the standard requirements, the State Food and Drug Administration has asked the provincial food and drug regulatory agencies where the enterprise in accordance with the "Medical Device Supervision Regulations" "General Office of Food and Drug Administration on further strengthening of medical (SFDA) [2016] No. 9), investigate and handle related enterprises, supervise the implementation of product recall, reason investigation of nonconformities, corrective measures and information on public disclosure; Product is harmful to the human body or there is evidence that it may harm the human body health They shall, according to law, take emergency control measures of suspending the production, operation and use of the foodstuffs and, if the import is temporarily suspended, make an administrative decision in a timely manner to the SAFE. Where the enterprise fails to fulfill the above requirements, the local food and drug supervision and administration department at the locality shall strictly follow the law Investigate and deal with the relevant information should be promptly made public.

Fifth, the implementation of the above, the relevant provincial food and drug supervision and management department in January 10, 2018 report to the Administration.

Special announcement.

Serial number	Mark the product name	Was spot checks	Marking manufacturers	Specification	Production date / serial number	Sampling unit	inspection entity	Does not meet the standard requirements
1	Beautiful new love soft hydrophilic contact lens	Shenzhen British Novartis optical technology Limited	Yu Jia Technology shares Limited	Light blue, green, purple, gray, brown, gold, black	/S15972	Guangdong Food and Drug Administration	Zhejiang Medical Devices Testing Institute	Radius of base arc or height of a given base diameter
2	Crystal color soft hydrophilic contact lens	Shenzhen British Novartis optical technology Limited	Yu Jia Technology shares Limited	Blue, brown, gray, purple, green, gold, black	/ DUA	Guangdong Food and Drug Administration	Zhejiang Medical Devices Testing Institute	Radius of base arc or height of a given base diameter
3	Soft and hydrophilic Contact lens	Jiangsu John Dragon Optical Co., Ltd.	Jiangsu John Dragon Optical Co., Ltd.	PRETTY-V	/150516C	Jiangsu Province Food and Drug Administration	Zhejiang Medical Devices Testing Institute	Oxygen permeability
4	Soft hydrophilic contact lens Soft Contact Lens	Shanghai High Le Bo Glasses Co., Ltd.	Korea GEO Medical Co., Ltd Agent: Shanghai Le Le Bo glasses Limited	IMAGE COLOR II X4U-245	Production Date: 2015/06 batch number: GFFE450508	Shanghai Food and Drug Administration	Zhejiang Medical Devices Testing Institute	1. The total diameter; 2. The base arc radius or given bottom diameter of the arrow-height
5	Soft and hydrophilic Contact lens	Guangzhou Qi Anqi Visual Technology Limited	Guangzhou Qi An Qi Vision Technology Co., Ltd.	Comfort.Ⅰ	Production date: 2015.04.02 2014.11.15 batch number: 201411-5 201504-1	Guangdong Food and Drug Administration	Zhejiang Medical Devices Testing Institute	Total diameter
6	Soft and hydrophilic Contact lens	Jilin Province Jingneng Glasses Co., Ltd.	(Taiwan) Precision Optical Co., Ltd.	iLens Daily	/ 0904P165209C1, 0912P165209C1, 0928P165209B1	Jilin Province Food and Drug Administration	Zhejiang Medical Devices Testing Institute	Total diameter
7	Soft and hydrophilic Contact lens	Blue new electrical integrated market in the United States clear glasses line	Shanghai Weikang Optical Glasses Co., Ltd.	1 piece / bottle butterfly color	Production Date: 2015-7-7 2015.11.6 2015.7.14 batch number: NZ007G07 NZ011G06 NZ007G14	Gansu Provincial Food and Drug Administration	Zhejiang Medical Devices Testing Institute	Total diameter
8	Soft and hydrophilic Contact lens	Qingdao Niubaba Yiou Optical Manufacturing Co., Ltd.	Qingdao Niubaba Yiou Optical Manufacturing Co., Ltd.	COSMETIC	16.05.18/	Shandong Province Food and Drug Administration	Zhejiang Medical Devices Testing Institute	Total diameter
9	Soft and hydrophilic Contact lens	Qingdao Niubaba Yiou Optical Manufacturing Co., Ltd.	Qingdao Niubaba Yiou Optical Manufacturing Co., Ltd.	COSMETIC	16.02.27/	Shandong Province Food and Drug Administration	Zhejiang Medical Devices Testing Institute	Total diameter
10	Soft and hydrophilic Contact lens	Xi'an Shu Bo Optical Technology Co., Ltd.	Qingdao Niubaba Yiou Optical Manufacturing Co., Ltd.	COSMETIC	20160226/	Shaanxi Provincial Food and Drug Administration	Zhejiang Medical Devices Testing Institute	1. Total diameter; 2. After vertex
11	Soft and hydrophilic Contact lens	Panjin image lean glasses Limited	Jing Shuo optical shares Limited	Light blue water content of 58%	Production Date: / 2015/01/16 2014/11/02 batch number: 05141101 05150116 02141102	Liaoning Province Food and Drug Administration	Zhejiang Medical Devices Testing Institute	UV zone requirements (when applicable)
12	Soft and hydrophilic Contact lens	Zhengzhou Jinshui Li Ming glasses culture Road shop	Jing Shuo Optical Co., Ltd.	Light blue water content of 58%	Production Date: 2015/12/11 2015/12/10 2015/08/14 batch number: 05151211 05141101 04151210 06151211 01150814	Henan Province Food and Drug Administration	Zhejiang Medical Devices Testing Institute	UV zone requirements (When applicable)
13	Soft and hydrophilic Contact lens	Liaoyang City, Hong Guang District, Shenyang old bright watch optical shop	Yongsheng Optical Co., Ltd.	Eye Secret Color throw for six months	Production date: 20150914 Batch number: H3B182AJRD H3B181AJRB H3B181AJRC H3B182AJRK H3B182AJRB H3B182AJRJ H3B183AJRA H3B182AJRA H3B182AJRI H3B182AJRF H3B182AJRH H3B182AJRC H3B182AJRG H3B181AJRE H3B181AJRF	Liaoning Province Food and Drug Administration	Zhejiang Medical Devices Testing Institute	UV zone requirements (When applicable)
14	Soft and hydrophilic Contact lens	Xi'an Qujiang New District (Daming Palace) eyes the United States glasses line	Yongsheng Optical Co., Ltd.	Eye Secret Color throw for six months	Production Date: 20150925 20150929 20150925 batch number: H6B067AJJA H6B071AJLJ H6B068AJJK	Shaanxi Provincial Food and Drug Administration	Zhejiang Medical Devices Testing Institute	UV zone requirements (when applicable)

Food and Drug Administration

December 13, 2017