Events

Device Recall AMO Tecnis 1Piece Intraocular Lens 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Abbott Medical Optics Inc (AMO) 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
    53781
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0605-2010
  • 사례 시작날짜
    2009-11-11
  • 사례 출판 날짜
    2010-01-12
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-07-25
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86507
  • 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
    Abbott medical optics (amo) has received complaints of some tecnis 1-piece iols (model zcb00) have adhered to the lens optic after insertion into the eye. this can lead to a need for additional manipulation to separate the haptics from the optic during surgery which could lead to an injury.
  • 조치
    Beginning on Friday, November 6, 2009, AMO began distribution of the Recall Notification Letter via Federal Express to the 874 AMO Tecnis 1-piece IOL customer accounts in the US. Included with the Recall Notification letter is a facsimile delivery confirmation that each customer was instructed to fax back to AMO to confirm receipt of the Recall Notification Letter. --- Beginning on Monday, November 9, 2009, AMO began distribution of the Recall Notification letter to the AMO Tecnis 1-piece IOL customer/distributors accounts outside the USA. "THIS RECALL NOTIFICATION DOES NOT INVOLVE TECNIS 1-PIECE IOL THAT HAVE BEEN IMPLANTED. ONCE THE HAPTICS HAVE BEEN SUCCESSFULLY DEPLOYED, THESE LENSES FUNCTION PROPERLY." Questions should be directed to an AMO Customer Service Representative at 1-877-AMO-4LIFE (1-877-266-4543).

Device

Device Recall AMO Tecnis 1Piece Intraocular Lens
  • 모델명 / 제조번호(시리얼번호)
    All Serial numbers of tecnis 1-Piece Intraocular Lenses that were processed through lens surface treatment at the AMO PR facility between May 19 and October 16, 2009 - with serial numbers ending in 0906, 0907, 0908, and 0909. and subset with serial numbers ending in 0905 and 0910.  Expiration/Use By Date (YYYY-MM): 2011-05, 2011-06, 2011-07, 2011-08, 2011-09, and 2011-10
  • 의료기기 분류등급
    Ophthalmic Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, NC, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY, Hawaii, and Puerto Rico. INTERNATIONAL: Austria, Azerbaijan, Belgium, Canada, Switzerland, Cyprus, Czech Republic, Germany, Estonia, Spain, Finland, France, United Kingdom, Hungary, Ireland, Israel, Italy, Lebanon, Lichtenstein, Libya, Martinique, Netherlands, Poland, Palestine, Portugal, Saudi Arabic, Sweden, Slovenia, Turkey, and South Africa.
  • 제품 설명
    AMO Tecnis 1-Piece Intraocular Lens (Model ZCB00)
  • Manufacturer
    Abbott Medical Optics Inc (AMO)

Manufacturer

Abbott Medical Optics Inc (AMO)
  • 제조사 주소
    Abbott Medical Optics Inc (AMO), 1700 E Saint Andrew Pl, Santa Ana CA 92705
  • 제조사 모회사 (2017)
    Johnson & Johnson
  • Source
    USFDA