Events

Alcon AcrySof IQ IOL with ULTRASERT Delivery System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Alcon Research, 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
    74824
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2708-2016
  • 사례 시작날짜
    2016-07-28
  • 사례 출판 날짜
    2016-09-01
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-06-07
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148530
  • 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 ultrasert delivery system from certain lots have an inferior surface characteristic that could result in the iol becoming lodged in the delivery system.
  • 조치
    Alcon Research sent an Urgent Field Safety Notice letter dated July 2016 to customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to check their inventory and segregate any product being recalled. Customers were asked to complete and return the Field Safety Notice Response Form. For questions or concerns contact Alcon.

Device

Alcon AcrySof IQ IOL with ULTRASERT Delivery System
  • 모델명 / 제조번호(시리얼번호)
    Lot numbers: 12407022, 12407085, 12407087, 12409013, 12409024, 12409026, 12409028
  • 의료기기 분류등급
    Ophthalmic Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Armenia, Belgium, Bulgaria, Croatia, Finland, France, Germany, Hungary, Italy, Lithuania, Malaysia, Netherlands, Norway, Poland, Portugal, Qatar, Romania, Slovenia, Spain, Sweden, Switzerland, Thailand, United Kingdom (Great Britain and Ireland), and United Arab Emirates. *** While this product is available in the US, these lots were not distributed to US consignees ***
  • 제품 설명
    Alcon AcrySof IQ IOL with ULTRASERT Delivery System || Product Usage: || The Alcon AcrySof IQ Intraocular Lens (IOL) is an acrylic foldable singlepiece posterior chamber lens for the replacement of the human crystalline lens in the visual correction of aphakia in adult patients following cataract surgery. This material is capable of being folded prior to insertion. The lens gently unfolds to a fullsize lens body following implantation. The lens has a biconvex optic with supporting haptics The AcrySof IQ IOLs are provided in the ULTRASERT Preloaded Delivery System for a convenient, controlled means to reliably place these lenses into the capsular bag.
  • Manufacturer
    Alcon Research, Ltd.

Manufacturer

Alcon Research, Ltd.
  • 제조사 주소
    Alcon Research, Ltd., 6201 South Fwy, Fort Worth TX 76134-2099
  • 제조사 모회사 (2017)
    Novartis Ag
  • Source
    USFDA