Events

Catalys Precision Laser System 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Abbott Medical Optics 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
    2015-03-16
  • 사례 출판 날짜
    2015-03-17
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150316a.html
  • 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
    Medical Device Safety Alert
  • 원인
    Medical device safety alert: abbott medical optics catalys precision laser system medical device manufacturer, abbott medical optics, has issued a medical device safety alert concerning catalys precision laser system [software version: 3.00.05]. the manufacturer identified two issues: loss of suction during treatment which may result in scoring the cornea during lens fragmentation. for the cataract incision surgeon templates with software version 3.00.05, selecting and deselecting an eye then selecting the other eye will result in templates for both eyes having the same parameters. the manufacturer has provided instructions on how to detect and respond to loss of suction, and advised users to verify the parameters, architecture and location of the cataract incisions in the cataract incision surgeon templates before saving and before treatment. the manufacturer will provide a software update to resolve the second issue. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 17 march 2015.

Device

Catalys Precision Laser System
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Abbott Medical Optics Catalys Precision Laser System
  • Manufacturer
    Abbott Medical Optics

Manufacturer

Abbott Medical Optics