Acuvue Advance. Technical Name: Contact Lenses. ANVISA registration number: 80148620026. Class of risk: II. Model Affected: N / A. Serial numbers affected: B00DHLP 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Johnson & Johnson Industrial Ltda; Johnson & Johnson Vision Care, Inc 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 사례 ID
    2414
  • 날짜
    2017-11-27
  • 사례 국가
  • 사례 출처
    ANVISA
  • 사례 출처 URL
  • 비고 / 경고
    Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
  • 데이터 추가 비고
    If you have received a potentially affected product, please follow these instructions: 1. Review your inventory and determine if you have any of the batches mentioned above under the ACUVUE® ADVANCE® brand; 2. If you have stock of the lots mentioned above, we ask that you suspend your marketing. You can continue to market all other lots not affected by this field action; 3. Please give this notice to anyone in your organization who needs to be aware of the field action and make sure they have knowledge as needed; 4. Contact Customer Service at 0800-728-8281 to coordinate the return of affected batches units and free replacement of the product; 5. Complete the response form below, even if there is no affected product in your inventory, and send via email to supportvistakon@conbr.jnj.com or through your JJVC sales representative. JJVC needs this information for reconciliation purposes. As always, any patient who has a complaint about ACUVUE® products is instructed to stop using it and immediately contact Johnson & Johnson Vision Customer Service (0800-762 5424), or the product has been purchased, or your ophthalmologist. If any user experiences persistent irritation, pain or redness, or any change in vision after removal of the lens, the user should contact his physician immediately. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link Additional information: - Date of identification of the problem by the company: 02/12/2013 - Date of notification notice to Anvisa: 11/24/2017 The company holding the record of the affected product is responsible for contacting its customers in a timely manner. to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "
  • 원인
    Johnson & johnson industrial ltda., is voluntarily collecting a batch of the product: acuvue advance, anvisa registration: 80148620026. this field action only affects the product of the batch: boodhlp (date of manufacture: 05/15/2012; expiry date: 08/2018). between 2013 and 2016, a total of 6 confirmed claims, 5 in japan and 1 in taiwan, are received worldwide associated with a cleaning brush bristle found between the primary packaging (blister) and aluminum foil (foil) . the bristles in question were part of a cleaning brush used periodically in our manufacturing process. no adverse events have been reported regarding this or similar situations. from the lot distributed in brazil, boodhlp, a claim was confirmed in japan: one from the boodhlp lot on 02/12/2013, internal identification number j & j ;: chs-0628024. there were no complaints in brazil or any other country in latin america.
  • 조치
    Field Action Code QRB-07-2017 triggered under the responsibility of Johnson & Johnson Industrial Ltda. Will Make Gathering

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