Events

Hydrophilic Acrylic Single Use lntraocular Lens system packs 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Kevin Grundy (IBD) 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-2015-RN-00180-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2015-03-23
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00180-1
  • 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
    Rayner through kevin grundy (ibd) pty ltd is informing the customers that certain products released to market contain an injector (individually wrapped within the product carton) that has a slightly shorter expiry date than the expiry date as shown on the outer carton. the affected lots may have an expiry date (on the outer carton) of november 2019, december 2019 or january 2020), the individually wrapped injector has its own expiry date marked on the tyvek lid. the expiry date of the associated injectors is around one month prior to that shown on the outer carton.There is no immediate issue associated with the use of the product. the affected product will not expire at least for four year and eight months.
  • 조치
    Kevin Grundy (IBD) Pty Ltd (for Rayner) is requesting the customers to return all the affected units. Rayner Intraocular Lenses Limited offers free replacementfor the products that are not intended to be used in the short term.

Device

Hydrophilic Acrylic Single Use lntraocular Lens system packs
  • 모델명 / 제조번호(시리얼번호)
    Hydrophilic Acrylic Single Use lntraocular Lens system packsProduct Model No.: 623TBatch Numbers: 65190, 64525, 64529, 64720, 65224,65224, 65251, 65544 ARTG Number 100926Product Model No.: 653LBatch Number:65122ARTG Number:1752621
  • Manufacturer
    Kevin Grundy (IBD) Pty Ltd

Manufacturer

Kevin Grundy (IBD) Pty Ltd