AERO IOL Injection System, Z28 Cartridges 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Aaren Scientific 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
    78037
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0071-2018
  • 사례 시작날짜
    2017-09-01
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2018-05-01
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Folders and injectors, intraocular lens (iol) - Product Code MSS
  • 원인
    The recommended storage temperature on the label is incorrect.
  • 조치
    Aaren Scientific sent an Urgent Medical Device Recall letter dated August 31, 2017. to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to do the following: 1.Compare your inventory against the above list. 2. STOP using and REMOVE from your inventory all affected Z28 listed above. 3. Complete and return the attached Customer Reply Form EVEN IF YOU HAVE NO INVENTORY affected by this recall, to Aaren Scientific, Inc. Quality Management at (909) 937-1033 or email to Z28recall.med.us@ZEISS.com within 3 business days of receipt of this letter. Upon notification, Aaren Scientific, Inc. will supply you with a Return Good Authorization Number to replace all remaining customer inventory of the affected product immediately. Aaren Scientific, Inc. requires this information for reconciliation purposes with regulatory agencies. No other Aaren Scientific, Inc. Z28 Cartridges are affected by this action. This notice should be shared with anyone who needs to be aware within your organization or to any organization where the potentially affected products have been transferred. If you have inventory of any of the Z28 Cartridges with the batch numbers listed, please contact Customer Support at (909) 937-1033 to arrange pick up of lenses to be returned. Page 2 of 4 If you have product complaints or adverse events to report regarding the use of the Z28 cartridge, please inform Aaren Scientific, Inc. by calling. When reporting a complaint, please provide the Z28 cartridge batch number and, if a patient was involved, the date of surgery, a description of the event and patient outcome. For questions regarding this recall call 909-906-5119.

Device

  • 모델명 / 제조번호(시리얼번호)
    Lot numbers and expiration dates: 160204, 1/31/2018; 160505, 4/30/2018; 161006, 9/30/2018; 161018, 9/30/2018; 161028, 9/30/2018; 161219, 11/30/2018; and 170120, 12/31/2018.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide distribution including Puerto Rico.
  • 제품 설명
    AERO IOL Injection System containing 10 Z28 Cartridges per box, Part #003500-0025-282, Sterile, Rx. The firm name on the label is Aaren Scientific Inc., Ontario, CA. || Used to fold and insert the firm's IOL's.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Aaren Scientific Inc., 1040 S Vintage Ave Ste A, Ontario CA 91761-3631
  • 제조사 모회사 (2017)
  • Source
    USFDA