Events

Next Generation Laser 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Alcon Laboratories, 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
    49600
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0274-2009
  • 사례 출판 날짜
    2008-11-06
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-03-07
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73896
  • 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
    Ophthalmic Laser - Product Code HQF
  • 원인
    Alcon had identified that indications for use unapproved by the food and drug administration are included in the purepoint laser system operator's manual, catalog number 8065751131, revision b.
  • 조치
    An Alcon representative has been provided with a package of information for each customer site. All domestic customers are being provided an Urgent: Medical Device Correction letter describing the change to the PurePoint Operator's Manual and are being issued a revised PurePoint Operator's Manual (Revision C). The letter advises that Alcon Research, Ltd, has initiated a voluntary correction based upon unapproved indications for use identified within the Alcon PurePoint Laser System Operator's Manual, Revision B. The letter advises that the following indications for use have been updated or removed on page 1.14, Professional Operator's Information, in Revision C of the PurePoint Laser System Operator's Manual: Updated: "AMD; Wet or Dry to include macular degeneration" has been updated to read "Choroidal neovascularization secondary to age-related macular degeneration (AMD)". "Trabeculoplasty for treatment of Chronic/Primary Open Angle Glaucoma (COAG, POAG), Acute Angle Closure Glaucoma (AACG), and refractory glaucoma" has been updated to read "Trabeculoplasty for treatment of Chronic/Primary Open Angle Glaucoma (COAG, POAG) and refractory glaucoma" Removed: Macular photocoagulation; including grid, focal, laser drusen scatter (panretinal) Transcleral cyclophotocoagulation Intra-ocular tumors; to include choroidal hemangioma, choroidal melanoma, retinoblastoma Otosclerotic hearing loss. No other changes to the manual have been made in this revision and no other Alcon products are affected by this correction. Per the letter, an Alcon Representative will provide customers with a new PurePoint Laser System Operator's Manual, Catalog Number 8065751131, Rev. C. and customers are return their existing PurePoint Laser System Operator's Manual, Catalog Number 8065751131, Rev.B. A signed confirmation of receipt of the letter is required from all customers.

Device

Next Generation Laser
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers 0801438901X, 0801481701X2, 0801591601X2, 0801591701X1, 0801591801X1, 0801692701X1, 0801717801X3, 0801717901X, 0801718001X1, 0801718101X, 0801718201X, 0801763401X1, 0801763601X, 0801817201X, 0801817601X, 0801844601X1, 0801844701X1, 0801844801X1, 0801844901X, 0801845001X1, 0801887201X, 0801887501X, 0801887601X, 0801965801X, 0801965901X, 0801966001X, 0802057301X, 0802057501X, 0802244501X, 0802244701X, 0802245101X, 0802480501X, 0802480901X, 0802484101X, 0802514101X, 0802529501X, 0802570101X, 0801887401X, 0802244301X, 0801439201X, and 0802244901X,
  • 의료기기 분류등급
    Ophthalmic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution --- USA including states of IL, WI, TX, MI, PA, NY, CT, SC, NC, LA, FL, GA, CA, OR, WA, CO, and NV, and countries of India, Bulgaria, Barbados, and Dominican Republic.
  • 제품 설명
    PurePoint System Operator's Manual, Catalog Number 8065751131, Rev. B for use with the Alcon PurePoint Laser, Catalog Number 8065750597 || Indicated for use in photocoagulation of both anterior and posterior segments of the eye.
  • Manufacturer
    Alcon Laboratories, Inc.

Manufacturer

Alcon Laboratories, Inc.
  • 제조사 주소
    Alcon Laboratories, Inc., 15800 Alton Pkwy, Irvine CA 92618
  • 제조사 모회사 (2017)
    Novartis Ag
  • Source
    USFDA