Avaira and BioComfort XO contact lenses 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 CooperVision 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
    2011-11-16
  • 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
    Recall of avaira and biocomfort xo contact lenses the department of health (dh) today (november 16) endorsed the recall of avaira and biocomfort xo contact lenses in hong kong as the product’s manufacturer in the united states, coopervision, has expanded its global recall of the avaira brand product line of contact lenses announced in august this year. a dh spokesman said the product’s local distributor, coopervision hong kong revealed that the lenses are being recalled because of the presence of silicone oil residue which may cause hazy vision or discomfort, severe eye pain or even eye injuries requiring medical treatment. the spokesman said that coopervision had recalled its avaira toric and biocomfort xo toric contact lenses in august this year, following complaints of discomfort and/or blurred vision from consumers. he further explained that in view of possible consumer safety concern and to avoid market confusion, a total recall of avaira and biocomfort xo contact lenses in hong kong is a prudent measure. dh will alert the hospital authority, private hospitals, relevant healthcare institutions, medical and optometrists associations about the matter. the company has also set up a hotline at 3718 0688 to answer enquiries. "members of the public should cease using the product if they feel unwell, and consult their healthcare providers. dh will continue the investigation and closely monitor the recall." ends/ wednesday, november 16, 2011.

Device

  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
  • 제품 설명
    Press release: Recall of Avaira and BioComfort XO contact lense
  • Manufacturer

Manufacturer