Events

Retiro De Equipo (Recall) de SoftPort EasyLoad Lens Delivery System

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Bausch & Lomb Surgical, Inc..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    77087
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2098-2017
  • Fecha de inicio del evento
    2017-04-05
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154943
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Folders and injectors, intraocular lens (iol) - Product Code MSS
  • Causa
    Complaints concerning kinked haptics that were occurring during lens delivery.
  • Acción
    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
  • Modelo / Serial
    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.
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    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
  • Descripción del producto
    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.
  • Dirección del fabricante
    Bausch & Lomb Surgical, Inc., 21 N Park Place Blvd, Clearwater FL 33759-3917
  • Empresa matriz del fabricante (2017)
    Bausch Health Cos., Inc.
  • Source
    USFDA