Events

Device Recall Healon EndoCoat Ophthalmic Viscosurgical Device and Healon Duet Dual Pack 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Abbott Medical Optics Inc (AMO) 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
    69704
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0530-2015
  • 사례 시작날짜
    2014-11-06
  • 사례 출판 날짜
    2014-12-12
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-05-19
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131399
  • 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
    Aid, surgical, viscoelastic - Product Code LZP
  • 원인
    Amo has received complaints where the finger grip dislodged while depressing the syringe plunger. the finger grip dislodgement could result in the surgeon's hand unintentionally moving the cannula further than intended, resulting in potential trauma to the eye.
  • 조치
    Abbott Medical Optics issued an Urgent Advisory Notice dated November 4, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to consult the DFU that is distributed with each device, which contains important warning and precautions for use of the product. Customers were instructed to provide a copy of the Advisory Notice to surgeons and thsoe who need to be aware in their organization. Custommers with questions were instructed to call 877-266-4543. For questions regarding this recall call 714-247-8656.

Device

Device Recall Healon EndoCoat Ophthalmic Viscosurgical Device and Healon Duet Dual Pack
  • 모델명 / 제조번호(시리얼번호)
    Part Number: US: VT585U and 57502000 (packaged in Healon Duet 10290080) OUS: VT585 57550500 (packaged in Healon Duet 10220010, 10220011, and 10220012)  Healon EndoCoat Device identification: For Healon EndoCoat, each lot is assigned a unique lot number for traceability. The lot number is a 6-digit numerical code that is equal to the manufacturing order number assigned. The numbers 1-6 are sequentially increased representing the manufacturing order number. Example: Lot 024992.   For Healon EndoCoat packaged in Healon Duet, each Healon Duet final product is identified witha unique batch number. The batch number consists of two alphabetic characters followed by five numeric characters. The first alphabetic character of each batch number designates the manufacturing site. The second alphabetic character of each batch number shall be sequential numbers starting with 30001. Example: Lot UP30729 (This lot number would represent the 729th unit manufactured by AMO in 2014).
  • 의료기기 분류등급
    Ophthalmic Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (Nationwide and Puerto Rico) and internationally to the following countries; Italy, Austria, Saudi Arabia, Turkey, Hong Kong, Canada, Germany, Australia, Columbia, Venezuela, Netherlands, Portugal, New Zealand, Denmark, Argentina, France, Belgium, Costa Rica, Singapore, Ukraine, Guadeloupe, Kuwait, Chile, Peru, Mexico, Czech Republic, Serbia, Hungary, Slovenia, Guatemala, Finland, Honduras, Malaysia, United Kingdom, Spain, Switzerland, Israel, and Croatia.
  • 제품 설명
    Abbott Healon EndoCoat Ophthalmic Viscosurgical Device || 3% sodium hyaluronate || 0.85 mL 30 mg/mL || Sterile A Solution || Sterile EO Packaging and Cannula || Product of USA || Abbott Healon Duet Dual Pack || 0.55 ml OVD || 0.85 ml Healon EndoCoat OVD || Contents: || -one sterile syringe of Healon Ophthalmic Viscosurgical Device (OVD) 0.55 ml (10 mg/ml Sodium Hyaluronate) || -one sterile syringe of Healon EndoCoat Ophthalmic Viscosurgical Device (OVD) 0.85 ml (30 mg/ml Sodium Hyaluronate) || Part Number: || US: VT585U and 57502000 (packaged in Healon Duet 10290080) || OUS: VT585 and 57550500 (packaged in Healon duet 10220010, 10220011 and 10220012)
  • Manufacturer
    Abbott Medical Optics Inc (AMO)

Manufacturer

Abbott Medical Optics Inc (AMO)
  • 제조사 주소
    Abbott Medical Optics Inc (AMO), 1700 E Saint Andrew Pl, Santa Ana CA 92705-4933
  • 제조사 모회사 (2017)
    Johnson & Johnson
  • Source
    USFDA