avaira toric and biocomfort xo toric contact lenses 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 CooperVision 에 의해 제조된 제품과 관련되어 있습니다.

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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
    2011-08-22
  • 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 toric and biocomfort xo toric contact lenses subsequent to department of health’s (dh’s) advice on suspension of use of avaira toric contact lenses over the weekend, the dh today (august 22) endorsed the recall of the avaira toric contact lenses and another product biocomfort xo toric contact lenses because further information from the distributor, coopervision hong kong, revealed that the product marketed as biocomfort xo toric brand, was the same product as avaira toric contact lenses in hong kong. a dh spokesman said upon further investigation, coopervision revealed that both the biocomfort xo toric and avaira toric were manufactured by the same manufacturer and the same production line. the biocomfort xo toric had been directly marketed only to the members of the hong kong association of private practice optometrists (appo) at their shops. dh advised over the weekend that consumers should suspend use of avaira toric contact lenses.  the advice followed the recall of avaira toric in the united states, australia, canada, germany, italy and spain after investigating into complaints of discomfort and/or blurred vision from consumers, which were likely to be due to transient swelling of the surface layer of the corneas brought about by a small amount of residues on the lens. consumers should also suspend the use of biocomfort xo toric because of the same defect. the spokesman further explained that in view of possible consumer safety concern, a total recall of the two products is a prudent measure. coopervision admitted that as revealed by the information at hand, the two products were the affected products identified so far.  dh will continue the investigation. dh had already alerted the hospital authority, private hospitals, relevant healthcare institutions and medical associations about the matter. coopervision hongkong has issued a letter to related eye care practitioners regarding the recall. the company has also set up a hotline at 3718 0602 to answer enquiries between 9 am and 5 pm from monday to friday. the spokesman said dh has so far not received any adverse reports arising from use of the products. "members of the public should consult their healthcare providers when in doubt and in particular, if they feel unwell after using the products. dh will continue the investigation and closely monitor the recall.” ends/.

Device

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

Manufacturer