Events

Viscocel and Viscocel Plus (Hydomethylpropcellulose) 2% Prefilled Syringes 1.5mL and 2.0mL 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Boucher & Muir 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-2013-RN-01262-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-12-06
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01262-1
  • 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
    Inspections findings by the fda noted deficiencies in the quality system regulations for medical device manufacturers relating to sterility and biocompatibility that may result in the release of contaminated products. no injuries have been reported for viscocel, however several cases of endophthalmitis reported to a related viscoelastic product in 2011 manufactured at the same facilities.
  • 조치
    Boucher & Muir is advising users to quarantine all units of the affected batches. Boucher & Muir is recovering affected stock and a credit note issued.

Device

Viscocel and Viscocel Plus (Hydomethylpropcellulose) 2% Prefilled Syringes 1.5mL and 2.0mL
  • 모델명 / 제조번호(시리얼번호)
    Viscocel and Viscocel Plus (Hydomethylpropcellulose) 2% Prefilled Syringes 1.5mL and 2.0mLProduct Codes: AusVIS15, AusVIS20Batch Numbers: 13D02 (expiry 04/2015), 12A13 (expiry 01/2015), 12J08 (expiry 10/2014), 13B18 (expiry 02/2015), 12J02 (expiry 10/2014), 12G16 (expiry 07/2014), 12I04 (expiry 09/2014) and 12H20 (expiry 08/2014)Manufactured from September 01, 2011 to September 19, 2013ARTG Number: 132648
  • 의료기기 분류등급
    Ophthalmic Devices
  • Manufacturer
    Boucher & Muir Pty Ltd

Manufacturer

Boucher & Muir Pty Ltd