Events

SoftPort EasyLoad Lens Delivery System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Bausch & Lomb Surgical, 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
    77087
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2098-2017
  • 사례 시작날짜
    2017-04-05
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154943
  • 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
    Complaints concerning kinked haptics that were occurring during lens delivery.
  • 조치
    Bausch & Lomb sent a Medical Device Recall letter dated April 18, 2017 to all their consignee informing them of the recall. Consignees were instructed to review their inventory and quarantine any unused product and return to Stericycle, the firm conducting this voluntary product recall on behalf of Bausch & Lomb. Contact Stericycle to arrange for a return at 1-877-469-8081. For replacement devices call 1-800-338-2020. Customers with questions were instructed to call 1-877-479-8081 or BauschandLomb5410@Stericycle.com. QUARANTINE PRODUCT AND RETURN TO BAUSCH + LOMB According to our records, your facility may have a supply of SofPort injection devices from the lots specified in this voluntary recall. We ask that you please quarantine any unused boxes (full and partial) and take the following steps to return the SofPort injection devices included in this voluntary recall to Stericycle, the firm conducting this voluntary product recall on behalf of Bausch + Lomb: 1. Please review your inventory and hold all unused (full and partial) boxes of SofPort injection devices. An example of the product label is provided below. 2. Complete the enclosed Medical Device Acknowledgement Form and return it to Stericycle. 3. Contact Stericycle to arrange for a return of the identified product in your facility at 1-877-479-8081. 4. Contact the Surgical Customer Service team to order replacement SofPort injection devices at 1-800- 338-2020. If you have questions or would like additional information, please call Stericycle, the firm conducting this voluntary recall on behalf of Bausch + Lomb, at 1-877-479-8081 or BauschandLomb5410@Stericycle.com.

Device

SoftPort EasyLoad Lens Delivery System
  • 모델명 / 제조번호(시리얼번호)
    Lot Number: H671901 Expiration Date: Dec-17,  Lot Number: H672001 Expiration Date: Nov-17, Lot Number: H672602 Expiration Date: Dec-17, Lot Number: H674001 Expiration Date: Dec-17, Lot Number: H674401 Expiration Date: Nov-17, Lot Number: H674801 Expiration Date: Dec-17, Lot Number: H675401 Expiration Date: Dec-17, Lot Number: H740301 Expiration Date: Dec-17, and  Lot Number: H743201 Expiration Date: Feb-18.
  • 의료기기 분류등급
    Ophthalmic Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, and Puerto Rico
  • 제품 설명
    SoftPort Easy-Load Lens Delivery System Model: EZ-28V || Is used for the folding and delivering of the LI61AO, LI61AOV, or LI61SE 3-piece lens into the eye. The SofPort Easy-Load Lens Delivery System consists of a syringe shaped body and tip with a plunger, drawer, and haptic puller. It is a sterile, disposable plastic device designed for single use only.
  • Manufacturer
    Bausch & Lomb Surgical, Inc.

Manufacturer

Bausch & Lomb Surgical, Inc.
  • 제조사 주소
    Bausch & Lomb Surgical, Inc., 21 N Park Place Blvd, Clearwater FL 33759-3917
  • 제조사 모회사 (2017)
    Bausch Health Cos., Inc.
  • Source
    USFDA