Events

INTRALASE FS Laser 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 AMO Manufacturing USA, LLC 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
    60241
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0167-2012
  • 사례 시작날짜
    2011-10-12
  • 사례 출판 날짜
    2011-11-04
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-05-01
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104855
  • 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
    Keratome, ac-powered - Product Code HNO
  • 원인
    The firm has identified a discrepancy in cut depth that may affect deep corneal incisions (e.G. 300 ¿m or deeper) created using the laser system.
  • 조치
    Abbott Medical Optics Inc. (AMO) issued an "ADVISORY NOTICE" letter dated October 12, 2011 to all affected customers. The letter identifies the affected products, the problem, and the actions needed to be taken. Customers were instructed to exercise caution when making cuts that approach the corneal endothelium. The letter includes a 1-page Operator's Manual addendum that clarifies the recommendations. The letter states that AMO will conduct a field correction to adjust the EOF on the affected FS Laser Systems. The letter includes a response form to be completed and returned as per the instructions. Customers were instructed to notify all appropriate staff/personnel of the Advisory Notice. For any further questions regarding the information or recommendations, contact an AMO representative at 1-800-266-3375

Device

INTRALASE FS Laser
  • 모델명 / 제조번호(시리얼번호)
    All units of these models (models 2, 3 and iFS) except model 1.
  • 의료기기 분류등급
    Ophthalmic Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide)
  • 제품 설명
    Abbott brand Advanced Femtosecond Laser Systems, Model iFS, Catalog Number: J20007D/J/K; || Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA || Product Usage: Intended Use for: IntraLase Femtosecond (Model 2 and 3) and iFS Advanced Femtosecond Laser Systems. FS Laser Systems are ophthalmic surgical lasers used in certain patient populations: (1) In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea; (2) In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments; (3) In lamellar IEK [lntraLase Enabled Keratoplasty] and corneal harvesting ; (4) In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea; (5) In the creation of a lamellar cut/resection of the cornea for lamellar IEK for the creation of a penetrating cut/incision for penetrating IEK.
  • Manufacturer
    AMO Manufacturing USA, LLC

Manufacturer

AMO Manufacturing USA, LLC
  • 제조사 주소
    AMO Manufacturing USA, LLC, 510 Cottonwood Dr, Milpitas CA 95035-7403
  • 제조사 모회사 (2017)
    Johnson & Johnson
  • Source
    USFDA