Events

Device Recall TECNIS CL 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 AMO Puerto Rico Manufacturing, 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
    68346
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2287-2014
  • 사례 시작날짜
    2014-05-13
  • 사례 출판 날짜
    2014-08-26
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-05-18
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128873
  • 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
    Units may be labeled with the incorrect diopter power.
  • 조치
    AMO sent an Urgent Medical Device Recall dated May 13, 2014 to the affected customers. The letter identified the affected product, problem and actions to be taken. This recall only affects the specific Silicone Tecnis IOLs Model Z9002. Implanted IOLs with appropriate post-op refractive outcomes are not affected by this recall. Please underatake the following actions: 1. Stop using and remove from your inventory the affected product. 2.Complete and return the included Facsimile Form as AMO. If you have inventory to return, please complete the Facsimile Form, and returned to AMO. For questions contact AMO Customer Service Representative 877-266-4543.

Device

Device Recall TECNIS CL
  • 모델명 / 제조번호(시리얼번호)
    Serial Num 1101821309 1101831309 1101841309 1101861309 1101881309 1101901309 1101921309 1101941309 1101981309 1101991309 1102001309 1102011309 1102031309 1102051309 1102071309 1102091309 1102111309 1102131309 1102201309 1102211309 1102221309 1102231309 1102241309 1102261309 1102271309 1102291309 1102301309 1102311309 1102321309 1102331309 1102351309 1102371309 1102381309 1102391309 1102401309 1102411309 1102431309 1102461309 1102481309 1102501309 1102551309 1102621309 1102641309 1102651309 1102661309 1102681309 1102811309 1102831309 1102851309 1102871309 1102911309 1102941309 1289831308 1289841308 1289851308 1289861308 1289871308 1289881308 1289891308 1289901308 1289911308 1289921308 1289931308 1289941308 1289961308 1290001308 1290021308 1290041308 1290061308 1290071308 1290081308 1290091308 1290101308 1290111308 1290121308 1290141308 1290161308 1290171308 1290181308 1290191308 1290201308 1290211308 1290231308 1290251308 1290271308 1290281308 1290291308 1290311308 1290321308 1290331308 1290341308 1290351308 1290361308 1290371308 1290381308 1039861309 1039881309 1039901309 1039961309 1039981309 1040011309 1040021309 1040041309 1040121309 1040151309 1040161309 1040171309 1040181309 1040191309 1040201309 1040211309 1040231309 1040251309 1040271309 1040291309 1040311309 1040331309 1040351309 1040371309 1040391309 1040471309 1040501309 1040551309 1040571309 1040591309 1040671309 1040711309 1040771309 1048531309 1048541309 1048551309 1048561309 1048571309 1048591309 1048601309 1048611309 1048621309 1048631309 1048641309 1048661309 1048671309 1048681309 1048691309 1048701309 1048711309 1048721309 1048731309 1048741309 1048751309 1048761309 1048771309 1048781309 1048801309 1048811309 1048841309 1048911309 1048921309 1048931309 1048941309 1048951309 1048971309 1048981309 1048991309 1049001309 1049021309 1049031309 1049041309 1049051309 1049071309 1049101309 1049121309 1049141309 1049161309 1049181309 1049201309 1049211309 1049221309 1049251309 1049271309 1049291309 1049321309 1049331309 1049341309 1049361309 1049371309 1049391309 1049401309 1049411309 1049421309 1049431309 1049441309 1049451309 1049461309 1049471309 1049481309 1049491309 1049501309 1049511309 1066121309 1066131309 1066161309 1066181309 1066211309 1066221309 1066231309 1066251309 1066261309 1066321309 1066361309 1066401309 1066441309 1066481309 1066521309 1066561309 1066571309 1066591309 1066601309 1066641309 1066661309 1066761309 1066951309 1066971309 1067041309 1067061309 1067081309 1067101309 1067121309 1067141309 1067151309
  • 의료기기 분류등급
    Ophthalmic Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - Nationwide (USA and Puerto Rico), and foreign: Latin America, Asia Pacific, Canada, Europe, Africa and Middle East, and Japan.
  • 제품 설명
    AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 29, 29.5 & 30. || Product Usage: || AMO TECNIS CL monofocal foldable IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag.
  • Manufacturer
    AMO Puerto Rico Manufacturing, Inc.

Manufacturer

AMO Puerto Rico Manufacturing, Inc.
  • 제조사 주소
    AMO Puerto Rico Manufacturing, Inc., Rd # 402, Km 4.2, Anasco PR 00610
  • Source
    USFDA