1 Day Acuvue TruEye 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Johnson & Johnson 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
  • 날짜
    2010-08-19
  • 사례 국가
  • 사례 출처
    DH
  • 사례 출처 URL
  • 비고 / 경고
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • 데이터 추가 비고
    Press release
  • 원인
    Voluntary recall of single-use contact lenses the department of health (dh) was notified by johnson & johnson (hk) limited today (august 19) that a voluntary recall of 16 batches of contact lens 1 day acuvue trueye is underway due to potential eye irritation or discomfort as a result of using the product. a dh spokesman said the affected batch was manufactured in ireland with lot numbers - 492237, 492238, 492241, 492245, 492250, 492251, 492252, 492254, 492268, 492280, 492281, 492282, 492283, 492287, 492288 and 492289. these numbers are the first six digits of the lot number printed at the side of the product box. according to johnson & johnson, the recall followed complaints regarding "unusual stinging or pain upon inserting of lens" reported in japan, which included stinging, ocular pain, redness and irritation. the investigation of the manufacturer so far showed that there was a problem in one portion of the lens rinsing process on a particular manufacturing line during a certain period of time. in hong kong, there has so far been no reported adverse events arising from use of the affected batches. according to the local supplier, about 3,715 boxes of the affected batches have been shipped out to optical outlets. the spokesman advised that members of the public should stop using the affected product and contact the company at their hotline, 2963 6799, for recall and product replacement. the hotline will operate from august 20 until september 22, daily between 9am and 6pm. the recall details can also be accessed at the website: www.Acuvue.Com.Hk. those who feel unwell after using the product should seek advice from their healthcare professionals. meanwhile, the dh has informed both public and private hospitals, relevant medical associations and optometrist associations about the issue. the recall will be closely monitored. ends/thursday, august 19, 2010.

Device

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Press release: Contact lens problems
  • Manufacturer

Manufacturer