Events

Rappel de Device Recall Raindrop Near Vision Inlay

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Revision Optics Inc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    76422
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1518-2017
  • Date de mise en oeuvre de l'événement
    2017-02-07
  • Date de publication de l'événement
    2017-03-21
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-06-21
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153166
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Implant, corneal, refractive - Product Code LQE
  • Cause
    Revision optics has updated the instructions for use (ifu) for the raindrop near vision inlay to emphasize that only balanced salt solution (bss) may be used to irrigate under the flap and that topical medications or lubricants should not be administered until centration of the inlay and proper flap positioning has been confirmed at the slit lamp.
  • Action
    A Dear Doctor letter was sent to inform customers that ReVision Optics wanted to share a surgical update regarding the Raindrop Near Vision Inlay procedure. Customers are informed that no ophthalmic medications or lubricants should be used immediately prior to or during placement of the Raindrop Near Vision Inlay. Only Balanced Salt Solution (BSS) should be used to irrigate under the flap during the Raindrop procedure. Customers are informed that ophthalmic medications or lubricants should be administered only after verifying proper inlay centration and flap positioning as observed at the slit lamp. This ensures that no further inlay or flap manipulation is required. ReVision Optics has updated the instructions for use (IFU) for the Raindrop Near Vision Inlay to emphasize that only BSS may be used to irrigate under the flap and that topical medications or lubricants should not be administered until centration of the inlay and proper flap positioning has been confirmed at the slit lamp. Customers with questions are instructed to contact Luis Vargas regarding the surgical procedure update.

Device

Device Recall Raindrop Near Vision Inlay
  • Modèle / numéro de série
    multiple lots since 08/01/2016
  • Classification du dispositif
    Ophthalmic Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    US: AL, AZ, CA, FL, GA, HI, IL, IN, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NY, OH, OK, PA, SD, TN, TX, UT, WA
  • Description du dispositif
    Raindrop Near Vision Inlay, Model# RD1-1
  • Manufacturer
    Revision Optics Inc

Manufacturer

Revision Optics Inc
  • Adresse du fabricant
    Revision Optics Inc, 25651 Atlantic Ocean Dr Ste A1, Lake Forest CA 92630-8835
  • Société-mère du fabricant (2017)
    ReVision Optics Inc.
  • Source
    USFDA