Some contact lenses have not reached the quality standard Johnson & Johnson and then trapped the \”recall door\”

Our reporter Zhang Yu Shanghai reported

As some contact lenses products have not met the quality standards, a few days ago, Johnson & Johnson Johnson \”Johnson & Johnson Vision Company\”) issued a statement saying that it has taken the initiative to recall AnTV Youli ⑧ Shuri ⑧ (30 tablets) specific batch number products.

Johnson & Johnson Visual Health Company said that the number of products affected by this recall is small, involving only 250 boxes of 250 boxes from five specific batch numbers. There is no relevant adverse reaction report in China.

It is worth noting that this is not the first time Johnson & Johnson recalls medical equipment products. According to the announcement of the State Drug Administration, in May of this year, Johnson & Johnson (Shanghai) Medical Equipment Co., Ltd. (hereinafter referred to as \”Johnson & Johnson Shanghai\”) reported that due to the problems involved in the product that may not be cut and nails, the producer ETHICNENNDO may occur. -Sur-Gery, LLC recalls three types of intra-cavity internal matchmakers with over 110,000 pieces. The recall level is first. Johnson & Johnson and Johnson & Johnson Shanghai are both subsidiaries of Johnson & Johnson (China) Investment Co., Ltd.

So, what are the specific aspects of the stealth lens products recalled by Johnson & Johnson\’s vision health company, and what is the progress of the recall? In this regard, on October 10, Johnson & Johnson Visual Heng Company responded to the reporter of China Business Daily and said that the reason for the recall was that some contact lens products did not meet the quality standards, and a few overseas consumers found floating in the plastic packaging of aluminum foil covering plastic packaging. Foreign objects in contact lenses or adheres to the lens.

\”We attach great importance to this issue, have taken action for the first time, start the procedure of active recall, and will continue to improve quality control. The current progress is smooth and destroyed as planned. It is not affected by this recall. AnViyou brand products can be used with confidence according to the instruction manual.

Slowly developing sound

From September 9th issued a statement in the Shanghai Food and Drug Administration to the official website of the British Drug Administration on September 26 At the relevant situation issued by Johnson & Johnson Visual Health Company on the Anteen Excellent website, Johnson & Johnson Visual Health Company did not publicize consumers within 7 days.

Review of the reporter found that as early as September 9 this year, according to the website of the Shanghai Food and Drug Administration, Johnson & Johnson vision health company received a limited number of complaints abroad, and the soft cornea contact mirror (product name:: Shuri scattered) The foreign body that floats in the contact lens solution or adheres to the lenses in the plastic packaging of aluminum foil covering plastic packaging. Johnson & Johnson vision health company actively recalls the specific 5 batch number soft cornea contact mirrors sold by it (product name: Shuri: Shuri: Shuri astigmatism). The recall level is second.

A report form of a medical device recall issued on the same day shows that the recall involves a total of 250 boxes of 5 batches of products, including 246 boxes that have been sold, 4 boxes of scrapped inventory, waiting to be destroyed Essence

However, for the recall, Johnson & Johnson\’s vision health company did not respond related on the company\’s official website at that time.

On September 26, the official website of the British Drug Administration (MHRA) released news that Johnson & Johnson recently took the initiative to recall the specific batch of Anteen\’s best -throwing contact lenses. MHRA urged users to view their use. Johnson & Johnson\’s ACUVUE1-DAY model.

MHRA said that the influential contact lens product or the soaking solution of contact lenses may contain particles. If these particulate matter is not noticed before wearing contact lenses, it may cause the eyes to become red, discomfort or discomfort or Corneal injury. So far, there are no reports of serious adverse events.

Markbirse, head of the MHRA equipment safety and supervision department, said: \”Although the risk is low, MHRA attaches great importance to the safety of the supervisory drugs and equipment. The current important thing is to make as much as possible as possible as possible Customers are aware that it is necessary to check these batch numbers on the lens. The official website issued a statement to explain the situation of the batches of the recalled contact lenses. Johnson & Johnson\’s Vision Health Company also said that the company attaches great importance to this issue. It has taken action for the first time, launched the procedure for active recall, and will continue to improve quality control.

The \”Administrative Measures for Medical Institution Recall\” newly revised in 2017 of the State Food and Drug Administration clearly states that according to the severity of medical device defects, medical device recalls are divided into: first -level recalls, secondary recalls, and third -level levels recall. Among them, the first -level recall refers to the use of this medical device may or has caused serious health hazards; the secondary recall refers to the use of this medical device may or has caused temporary or reversible health hazards; the third -level recall refers to the use of the medical treatment to use the medical treatment The possibility of harm caused by equipment is less likely but still needs to be recalled.

If the medical device manufacturer makes a medical device recall decision, the first -level recall should be within 1 day, and the second -level recall should be within 3 days. Unit or inform users.

From this calculation, from the issuance of a statement on the Shanghai Food and Drug Administration on September 9 to the official website of the British Drug Administration on September 26, then to Johnson & Johnson\’s vision health company. The relevant situation shows that Johnson & Johnson Vision Health Company did not publicize consumers within 7 days.

\”Protecting consumer eye health is our primary responsibility. Johnson & Johnson\’s vision health will be tested and sampled by strict testing and sampling before investing in the market to ensure that the product meets the factory before leaving the factory. All our requirements will be investigated immediately when the bias appears to find out the root cause and evaluate whether to take corrective measures in the production process. After the reason is found outActively take measures to add additional protective devices to the production line, and update preventive maintenance procedures and processes, further strengthening quality supervision. Johnson & Johnson Visible Health Company will, as always, will provide consumers with safe and effective products. \”The relevant person in charge of Johnson & Johnson\’s Vision Health Company responded.

Its products have been recalled frequently

In fact, this is not the first time Johnson & Johnson recalls similar products. /P>

Public information shows that Johnson & Johnson was founded in 1886 and involves three major areas of consumer goods, pharmaceuticals, and medical equipment. Johnson & Johnson\’s replacement contact lenses, headquartered in Jacksonville, Florida, USA.

In fact, this is not the first time that Johnson The bureau announced that in May of this year, Johnson & Johnson (Shanghai) Medical Equipment Co., Ltd. (hereinafter referred to as \”Johnson & Johnson Shanghai\”) reported that due to the problem that the product may occur in the occurrence of the padding and adverse incidents, the manufacturer EThiconndo-Surgery, LLC, LLC There are more than 110,000 internal involved in the three types of cavity. The problem of the line may have the risk of anastomosis, gastrointestinal damage, bleeding or blood loss shock after surgery. , The pads caused by the internal curved cavity inner cavity are not cut and adequate incidents, which may affect the integrity of the matching line. It has been released on April 11, 2019, and the recall level is second. \”Management Measures\”, if the first -level recall is implemented, the announcement of the recall of medical device shall be released on the website of the State Food and Drug Administration and the main media of the central government; if the implementation of the second and third -level recalls, the medical device recall announcement shall be in the province, the autonomous region, and the municipality directly under the Central Government. The website of the drug supervision and management department is released. In the news of the recall of medical device issued by the Pharmaceutical Regulatory Bureau, the product name of Johnson & Johnson\’s vision health company named \”Ou Shu San Grand\” actively recalls. When the recall is the internal survey of the company, some products with a batch number B00RWF0 have not reached additional packaging. Sealing test standard

According to Fuyun data, on March 8, 2019, Johnson & Johnson producer EThiconllc on polyester non -absorbing sutures actively recalls. JohnsonThe main body of the country is Johnson & Johnson (China) Co., Ltd., which was established in 1992. It is the first wholly -owned enterprise established by Johnson & Johnson in China. The company\’s legal representative is Xie Bing, behind the American Johnson & Johnson and Belgian Yangsen Pharmaceutical Co., Ltd.

According to Johnson & Johnson\’s 2018 report, in 2018, Johnson realized total revenue of US $ 81.582 billion, an increase of 6.7%compared to 2017. Among them, pharmaceutical business revenue was US $ 40.734 billion, an increase of 12.4%year -on -year. Consumer health products and medical device business segments increased by 1.8%and 1.5%year -on -year. Among the three major sectors, medical device business has the least increase.

According to Johnson & Johnson\’s second quarter report, according to the sales of the business department, the sales of medical device products in the first six months of 2019 were $ 12.9 billion, a year -on -year decrease of 5.7% Essence Among them, the sales of American medical device declined 3.6%, and the sales of international medical device declined by 7.6%.