FDAFDA · Alimentos y medicamentos·N.º oficial Z-2098-2017
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.
Publicado el 24 de mayo de 2017 · Inicio del retiro: 5 de abril de 2017
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
Complaints concerning kinked haptics that were occurring during lens delivery.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Bausch & Lomb Surgical, Inc.
- Distribuidor
- 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
- Lote
- 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 de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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