Events

LenSx Laser System with Corneal Flap Capability (used to perform corneal flaps in LASIK surgery or other treatment involving the incision of the cornea) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Alcon Laboratories Australia 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-2016-RN-00522-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-04-27
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00522-1
  • 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
    Alcon is conducting a recall for product correction of all lensx laser systems with corneal flap capability after receiving reports concerning incomplete corneal flap creation, which manifests as un-dissected area(s) within the side cut. if an un-dissected area in the side cut is observed, it may cause difficulty lifting the flap, potentially resulting in corneal tear, irregular stromal bed, or a corneal epithelial defect. this issue has been confirmed to manifest in only a small number of systems through the normal installation setup and optimisation process.
  • 조치
    Alcon is advising users that the LenSx system can continue to be used, and to exercise professional medical judgement when determining the management of potential side cut issues. Alcon will be implementing a software upgrade in order to minimise any incomplete areas within the side cut. This action has been closed-out on 03/02/2017.

Device

LenSx Laser System with Corneal Flap Capability (used to perform corneal flaps in LASIK surgery o...
  • 모델명 / 제조번호(시리얼번호)
    LenSx Laser System with Corneal Flap Capability (used to perform corneal flaps in LASIK surgery or other treatment involving the incision of the cornea)Catalogue Number: 8065998162 ARTG Number: 181017
  • Manufacturer
    Alcon Laboratories Australia Pty Ltd

Manufacturer

Alcon Laboratories Australia Pty Ltd