Events

Device Recall VisuMax Laser Keratome 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Carl Zeiss Meditec AG 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
    67440
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1153-2014
  • 사례 시작날짜
    2014-02-03
  • 사례 출판 날짜
    2014-03-07
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-03-07
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125453
  • 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
    Laser, ophthalmic - Product Code HQF
  • 원인
    Carl zeiss treatment pack, lot number m 130010, size m, may actually contain size s.
  • 조치
    The firm, Zeiss, sent an "Important Field Safety Advisory Note" letter dated February 3, 2014 to its customer. Letter indicates that a phone call preceded the letter on January 23, 2014. The letter also describes the product, problem and actions to be taken. The customers were instructed to quarantine all treatment packs size "M", batch number M 130010; return the material to Carl Zeiss Meditec, Inc., 5160 Hacienda Dr, Dublin, CA 94568 and Zeiss will issue a credit for all material received, upon receipt of the returned materia, and to complete and return the Conformation Form with the envelop provided. If you have any questions regarding this field corrective action, please call 925-557-4832 or email at paul.shahan@zeiss.com.

Device

Device Recall VisuMax Laser Keratome
  • 모델명 / 제조번호(시리얼번호)
    P/N 1462-333, Size M, Lot # M130010
  • 의료기기 분류등급
    Ophthalmic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Distribution: NV only.
  • 제품 설명
    Treatment packs used on the VisuMax Laser Keratome. || Size M || Manufactured by Carl Zeiss Meditec AG, || Jena, Germany. || The VisuMax Laser Keratome is indicated for the following: In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring lamellar resection of the cornea. Patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea. In the creation of a lamellar cut/resection of the cornea for lamellar keratoplasty. In the creation of a cut/incision for penetrating keratoplasty and corneal harvesting.
  • Manufacturer
    Carl Zeiss Meditec AG

Manufacturer

Carl Zeiss Meditec AG
  • 제조사 주소
    Carl Zeiss Meditec AG, Carl Zeiss Promenade 10, Jena Germany
  • 제조사 모회사 (2017)
    Carl-Zeiss-Stiftung
  • Source
    USFDA