Events

Various Acuvue for Astigmatism Contact Lenses 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Johnson & Johnson Pacific Pty Ltd 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    RC-2017-RN-01377-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2017-11-01
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01377-1
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
  • 데이터 추가 비고
  • 원인
    Johnson & johnson vision care (jjvc) has identified quality issues identified with specific batches of acuvue contact lenses. a limited number of confirmed reports were received in relation to a foreign matter visible within the contact lens package and a lens being “off power”. foreign matter - a limited number of reports of a brush bristle found between the blister package and foil have been received.Off power - a limited number of confirmed reports of a lens being “off power” have been received, where a consumer may recognise as not accurately correcting the vision in one eye (some distortion or blurriness). not all lenses in these lots are affected and there is no significant health risk related to this issue.To date, there have been no adverse events related to these issues.
  • 조치
    Eye Care Professionals are advised to check stock and quarantine the affected lot numbers. Affected stock can be returned for unaffected product.

Device

Various Acuvue for Astigmatism Contact Lenses
  • 모델명 / 제조번호(시리얼번호)
    Various Acuvue for Astigmatism Contact LensesAcuvue Oasys for Astigmatism, 8.6 -6.00 -1.75/170 6P and 8.6 -3.50 -0.75/180 6PLot Numbers: B00GW4Z and B00HRMGExpiry: Nov 2018 and Jul 2019Acuvue Oasys, 8.8 -04.00 6P RXLot: L002NCSExpiry: May 2020Acuvue Oasys, 8.8 -04.50 6PLot: L002QH9Expiry: Aug 20201 Day Acuvue Moist for Astigmatism, 8.5 -7.50 -1.25/180 90PLot: F00LF41Expiry: Apr 2021ARTG Numbers: 223534, 223535, 223536 and 154490
  • Manufacturer
    Johnson & Johnson Pacific Pty Ltd

Manufacturer

Johnson & Johnson Pacific Pty Ltd