Events

Rayner Intraocular Lenses - Sulcoflex Aspheric 653L, Sulcoflex Torie 653T, C-flex Aspheric 970C, Superflex Aspheric 920H, Sulcoflex Aspherie 653L, T-flex Aspheric 623T 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-2016-RN-00044-2
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2016-01-13
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00044-2
  • 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
    Internal quality checks by the manufacturer rayner have revealed that certain products released to market may contain a higher than usual level of residual polishing compound (aluminium oxide) that is used in the manufacturing process of intraocular lenses (iols). there is a possibility that certain products released to market may contain levels that slightly exceed the internal limits for residual aluminium oxide levels. clinically significant levels of aluminium oxide have, on rare occasions been linked to cases of toxic anterior segment syndrome (tass) in published literature.
  • 조치
    Customers are advised to inspect their stock and quarantine all affected stock so that Designs For Vision Pty Ltd (distributor) can arrange for quarantined stock to be recovered and replacement stock, or a credit note, issued. Surgeons are advised that if a lens subject to this recall has been implanted, it is recommended that as a precaution, healthcare professionals monitor patients for up to one month post-operatively for symptoms of TASS, in case of late onset presentation. This action has been closed-out on 09/05/2017.

Device

Rayner Intraocular Lenses - Sulcoflex Aspheric 653L, Sulcoflex Torie 653T, C-flex Aspheric 970C, ...
  • 모델명 / 제조번호(시리얼번호)
    Rayner Intraocular Lenses - Sulcoflex Aspheric 653L, Sulcoflex Torie 653T, C-flex Aspheric 970C, Superflex Aspheric 920H, Sulcoflex Aspherie 653L, T-flex Aspheric 623TMultiple Models and Lot Numbers affectedARTG Number: 100926
  • Manufacturer
    Kevin Grundy (IBD) Pty Ltd

Manufacturer

Kevin Grundy (IBD) Pty Ltd