Events

Device Recall OptiMedica Catalys 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Optimedica Corporation 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
    67150
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0649-2014
  • 사례 시작날짜
    2013-12-20
  • 사례 출판 날짜
    2014-01-08
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-06-26
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124783
  • 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 femtosecond laser - Product Code OOE
  • 원인
    Potential for unexpected heating of the transformer mounting bolt located within the system chassis and the subsequent melting of a non-slip computer shelf mat, which may manifest an odor and visible smoke.
  • 조치
    The firm, OptiMedica, issued an "ADVISORY NOTICE" dated December 20, 2013 to all customers with a Catalys Precision Laser System via Federal Express. OptiMedica also released a Field Service Bulletin (Document No: SB-00065) internally for the impacted product with instructions to implement the corrections through the OptiMedica service organization. The notice describes the product, problem and actions to be taken. The customers were instructed to complete the site header information on the attached fax-back form and return via fax to 1-408-890-4681 within the next three (3) business days or mail to OptiMedica at 1310 Moffette Park Drive, Sunnyvale, CA 94089. If you have any questions related to the operation of the Catalys Precision Laser System or the documentation requirements associated with this letter, please call OptiMedica Technical Support at 1-855-662-0911 and you will be directed to an OptiMedica representative who will be pleased to assist you.

Device

Device Recall OptiMedica Catalys
  • 모델명 / 제조번호(시리얼번호)
    All units shipped prior to Octotber 18, 2013. US Serial numbers: 44055311, 44055611, 44055811, 44056012, 44056312, 44056612, 44056712,  44056812, 44057312, 44057812, 44058012, 44058212, 44058312, 44059212, 44059312, 44059612, 44059712, 44059812, 44059912, 44060012, 44060112, 44060312, 44060412.  International Serial numbers: 44000811, 44055211, 44055411, 44055711, 44055911, 44056112, 44056212, 44056412, 44056512, 44056912, 44057012, 44057112, 44057212, 44057412, 44057512, 44057612, 44057712, 44057912, 44058112, 44058512, 44058612, 44058912, 44059012. 44059112 44059412 44059512 44060212 44060512 44061112 44061212 44061312 44061512 44061712 44061913 44062113 44062313 44062513 44062913 44063013 44060612 44060712 44060912 44061012 44061412 44061612 44061812 44062013 44062213 44062613 44062813 44063313 44063513 44063613 44063713 44063913.
  • 의료기기 분류등급
    Ophthalmic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: US (nationwide) including states of: TX, NC, OH, IA, UT, KY, ME, CA, NY, MA. NJ, IL, PA,, TN, FL, MO, GA, HI, SC, NE, MI, and GA and countries of: Dominican Republic, Germany, Switzerland, Australia, Spain, Japan, United Kingdom, Canada, France, The Netherlands, Austria, and Singapore.
  • 제품 설명
    Catalys Precision Laser System (United States) - Catalys-U: || Catalys Precision Laser System (International) - Catalys I || 200-240V ~, 50/60 Hz, 15A, || (2) 15A Resettable CB: || Tested and complies with FCC Part 15 Class A. || OptiMedica || 1310 Moffett Park Drive || Sunnyvale, CA 94089 || The OptiMedica Catalys Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens.
  • Manufacturer
    Optimedica Corporation

Manufacturer

Optimedica Corporation
  • 제조사 주소
    Optimedica Corporation, 1310 Moffett Park Dr, Sunnyvale CA 94089-1133
  • 제조사 모회사 (2017)
    Johnson & Johnson
  • Source
    USFDA