Events

EasySept HYDRO+ (3% hydrogen peroxide) Cleaning & Disinfecting Solution (Contact lens care kit) Affected Products :EasySept HYDRO + Duo Pack 480 mL EasySept HYDRO+ Value Pack 840 mL Easy Sept HYDRO + Starter Kit 120 mL 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 iNova Pharmaceuticals 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-01467-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-11-16
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01467-1
  • 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
    This recall has been initiated as a precautionary measure based on internal testing that simulated normal product use. there have been occasional occurrences where the residual peroxide remaining in the lens case after neutralisation was above product specification. this could lead to the user experiencing temporary ocular symptoms such as burning/stinging, irritation, and red eye.
  • 조치
    Pharmacists and optometrists are advised to quarantine affected stock and to return them to the place of purchase for a credit. They are also advised that should a consumer return any stock affected by this issue; please offer them a full refund. Wholesalers are advised to immediately quarantine and destroy all affected/returned stock.

Device

EasySept HYDRO+ (3% hydrogen peroxide) Cleaning & Disinfecting Solution (Contact lens care kit) A...
  • 모델명 / 제조번호(시리얼번호)
    EasySept HYDRO+ (3% hydrogen peroxide) Cleaning & Disinfecting Solution (Contact lens care kit)Affected Products :EasySept HYDRO + Duo Pack 480 mL EasySept HYDRO+ Value Pack 840 mL Easy Sept HYDRO + Starter Kit 120 mL All Batches ARTG Number: 203455
  • Manufacturer
    iNova Pharmaceuticals Australia Pty Ltd

Manufacturer

iNova Pharmaceuticals Australia Pty Ltd