Events

Ophthalmic implant Raindrop Near Vision Inlay 를 위한 안전성 경고 / 현장 안전성 서한

Medicines and Healthcare products Regulatory Agency에 따르면, 해당 안전성 경고 / 현장 안전성 서한 는 United Kingdom 에서 ReVision Optics, Inc 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

현장 안전성 서한은 의료기기 제조사 또는 제조사 대리인이 시중에 유통되고 있는 자사 의료기기 제품에 대하여 취할 수 있는 조치를 알리는 소통방식입니다. 주요 대상층은 보건의료업계 종사자와 의료기기 사용자들입니다. 여기에는 회수(recall) 조치와 경고도 포함될 수 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert / Field Safety Notice
  • 날짜
    2018-02-13
  • 사례 출판 날짜
    2019-02-13
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://www.gov.uk//drug-device-alerts/ophthalmic-implant-raindrop-near-vision-inlay-risk-of-corneal-haze-mda-2019-007
  • 비고 / 경고
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • 데이터 추가 비고
    The USA’s Food and Drug Administration (FDA) issued a safety communication informing users that implantation of this device has led to an increased occurrence of corneal haze.The cited study shows that 75% of 150 enrolled patients developed corneal haze. In 42% of patients, the corneal haze has been present in the central region of the cornea.There is no specific guidance regarding frequency of follow-up from the manufacturer; the clinician should assess the risk of corneal haze in individual patients.It is unknown how many Raindrop Near Vision Inlay devices may be placed on the market in the UK.
  • 원인
    Manufactured by revision optics, inc – patients implanted with this device have an increased risk of corneal haze.
  • 조치
    Do not implant Raindrop Near Vision Inlays. Identify all unused stock of Raindrop Near Vision Inlays and dispose of them. Monitor patients who have the inlay implanted or have previously had the device explanted for the development of corneal haze. The frequency of follow up should be determined by individual patient risk assessment. Report adverse events involving these devices through your local incident reporting system and/or your national incident reporting authority as appropriate: England, Scotland, Northern Ireland, Wales. You should also report directly to manufacturers if your local or national systems do not.

Device

Ophthalmic implant Raindrop Near Vision Inlay
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    The device is a corneal inlay (corneal implant) used to improve near vision.
  • Manufacturer
    ReVision Optics, Inc

Manufacturer

ReVision Optics, Inc
  • 제조사 주소
    ReVision Optics, the manufacturer of this device, ceased operations in 2018 and no contacts are available. Due to the lack of information on the distribution of this device, the MHRA is publishing this alert as a precautionary notice.
  • 제조사 모회사 (2017)
    ReVision Optics Inc.
  • Source
    MHRA