Events

Device Recall iSymm Intraocular Lens (Model FC60AD) 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Hoya Surgical Optics, Inc. 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
    59207
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2801-2011
  • 사례 시작날짜
    2011-06-17
  • 사례 출판 날짜
    2011-07-14
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-11-29
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=101697
  • 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 hoya surgical optics has confirmed that the isymm intraocular lens (model fc-60ad) and isert intraocular lens (model pc-60ad) have been sold and marketed with out an fda approval.
  • 조치
    Hoya Surgical Optics Inc. sent an "URGENT MEDICAL DEVICE REMOVAL" letter dated June 22, 2011 to all affected customers. The letter identifies the product, problem, and the actions to be taken. The letter instructs customers to quarantine affected product and return to HSO at their earliest convenience. Shipping instructions are included in the letter. Customers are to complete an Effectiveness Check Questionnaire and fax it to 1-909-680-3986. Questions regarding the recall process are directed to Hoya Customer Service at 1-866-750-5870 or e-mail at customercare@hoyasurgopt.com.

Device

Device Recall iSymm Intraocular Lens (Model FC60AD)
  • 모델명 / 제조번호(시리얼번호)
    This recall pertains to all serial numbers of I-ISO Model FC-60AD & PC-60AD lenses shipped to the U.S. and affected by this recall. A list of all affected serial numbers will be provided to the FDA LA District office. The total number of products on recall are 4522 different serial numbers on a excel spread sheet that will be attached when the Recall recommendation is sent to CDRH.
  • 의료기기 분류등급
    Ophthalmic Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution
  • 제품 설명
    iSymm Intraocular Lens (Model FC-60AD) || The Hoya iSymm Model FC-60AD Intraocular Lens (IOL) is an ultraviolet-light absorbing posterior chamber intraocular lens designed to be implanted posterior to the iris where the lens will replace the optical function of the natural crystalline lens. However, accommodation will not be replaced. The optic of this lens is designed to produce negative spherical aberration. The Hoya iSymm Model FC-60AD Intraocular Lens 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
    Hoya Surgical Optics, Inc.

Manufacturer

Hoya Surgical Optics, Inc.
  • 제조사 주소
    Hoya Surgical Optics, Inc., 14768 Pipeline Ave, Chino Hills CA 91709-3594
  • 제조사 모회사 (2017)
    Hoya Surgical Optics Inc.
  • Source
    USFDA