Events

EC3 Precision Aspheric Lens Intraocular Lens 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Aaren Scientific, Incorporated 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
    60962
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-1077-2012
  • 사례 시작날짜
    2011-08-02
  • 사례 출판 날짜
    2012-02-22
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-08-10
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106906
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Intraocular lens - Product Code HQL
  • 원인
    The recall was initiated because aaren scientific has confirmed that a specific group of lenses were shipped without a complete expiry date showing on the label.
  • 조치
    Aaren Scientific sent a recall communication letter dated August 2, 2011, August 3, 2011, and August 30, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Aaren Scientific is requesting that you return the lenses and we will rework the product and return them back to you. Please let me know and I will issue an RGA number and inform you of our FedEx account number to reference. In the meantime, we are conducting an internal investigation regarding this issue. Once this has been closed out then we will notify you of our findings. For further questions please call (909) 937-1033 ext. 108.

Device

EC3 Precision Aspheric Lens Intraocular Lens
  • 모델명 / 제조번호(시리얼번호)
    Lot Number: 110617
  • 의료기기 분류등급
    Ophthalmic Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - USA including CA and TN, and the countries of India and Lebanon.
  • 제품 설명
    Precision Aspheric Lens (PAL) Intraocular Lens || Model: EC-3 PAL, || Serial Number: 1169381106, 1169391106, 1169421106 || The device is indicated for primary implantation in the capsular bag of the eye for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed.
  • Manufacturer
    Aaren Scientific, Incorporated

Manufacturer

Aaren Scientific, Incorporated
  • 제조사 주소
    Aaren Scientific, Incorporated, 4290 E Brickell St Ste A, Ontario CA 91761-1569
  • 제조사 모회사 (2017)
    Carl-Zeiss-Stiftung
  • Source
    USFDA