Events

Device Recall STAAR Surgical Collamer UltravioletAbsorbing Posterior Chamber Single 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Staar Surgical Co. 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
    59028
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2706-2011
  • 사례 시작날짜
    2011-05-20
  • 사례 출판 날짜
    2011-06-29
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-03-04
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100868
  • 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 by staar surgical due to an error in the directions for use (dfu) for staar surgical's collamer ultraviolet absorbing posterior chamber single piece foldable intraocular lens (collamer ip iol), also known as the nanoflex iol. the device description erroneously indicates that the lens could be implanted in the ciliary sulcus.
  • 조치
    Staar Surgical send out an URGENT - Medical Device Correction Notice to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to acknowledge receipt of the letter by signing, dating, and faxing the form to Staar Surgical. For any questions call (800) 292-7902, ext 2345.

Device

Device Recall STAAR Surgical Collamer UltravioletAbsorbing Posterior Chamber Single
  • 모델명 / 제조번호(시리얼번호)
    CC4204BF and CC4204A
  • 의료기기 분류등급
    Ophthalmic Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - USA (nationwide) and the countries of South Africa, Slovakia, Mexico, Hong Kong, and Sri Lanka
  • 제품 설명
    Brand Name || STAAR Surgical Collamer¿ Ultraviolet-Absorbing Posterior Chamber Single || Piece Foldable Intraocular Lens || Common Names || Collamer single piece IOL || Collamer plate haptic IOL || The Device is intended to correct aphakia in persons 60 years of age or older in whom a cataractous lens has been removed by cataract extraction. The Device is to be implanted in the posterior chamber and in the capsular bag through a tear-free capsulorhexis (circular tear anterior capsulotomy).
  • Manufacturer
    Staar Surgical Co.

Manufacturer

Staar Surgical Co.
  • 제조사 주소
    Staar Surgical Co., 1911 Walker Ave, Monrovia CA 91016-4846
  • 제조사 모회사 (2017)
    Staar Surgical Co.
  • Source
    USFDA