Events

Alerte Ou Avis De Sécurité sur Ophthalmic implant Raindrop Near Vision Inlay

Selon Medicines and Healthcare products Regulatory Agency, ce/cet/cette alerte ou avis de sécurité concerne un dispositif en/au/aux/à United Kingdom qui a été fabriqué par ReVision Optics, Inc.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert / Field Safety Notice
  • Date
    2018-02-13
  • Date de publication de l'événement
    2019-02-13
  • Pays de l'événement
    United Kingdom
  • Source de l'événement
    MHRA
  • URL de la source de l'événement
    https://www.gov.uk//drug-device-alerts/ophthalmic-implant-raindrop-near-vision-inlay-risk-of-corneal-haze-mda-2019-007
  • Notes / Alertes
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
  • Notes supplémentaires dans les données
    The USA’s Food and Drug Administration (FDA) issued a safety communication informing users that implantation of this device has led to an increased occurrence of corneal haze.The cited study shows that 75% of 150 enrolled patients developed corneal haze. In 42% of patients, the corneal haze has been present in the central region of the cornea.There is no specific guidance regarding frequency of follow-up from the manufacturer; the clinician should assess the risk of corneal haze in individual patients.It is unknown how many Raindrop Near Vision Inlay devices may be placed on the market in the UK.
  • Cause
    Manufactured by revision optics, inc – patients implanted with this device have an increased risk of corneal haze.
  • Action
    Do not implant Raindrop Near Vision Inlays. Identify all unused stock of Raindrop Near Vision Inlays and dispose of them. Monitor patients who have the inlay implanted or have previously had the device explanted for the development of corneal haze. The frequency of follow up should be determined by individual patient risk assessment. Report adverse events involving these devices through your local incident reporting system and/or your national incident reporting authority as appropriate: England, Scotland, Northern Ireland, Wales. You should also report directly to manufacturers if your local or national systems do not.

Device

Ophthalmic implant Raindrop Near Vision Inlay
  • Modèle / numéro de série
  • Description du dispositif
    The device is a corneal inlay (corneal implant) used to improve near vision.
  • Manufacturer
    ReVision Optics, Inc

Manufacturer

ReVision Optics, Inc
  • Adresse du fabricant
    ReVision Optics, the manufacturer of this device, ceased operations in 2018 and no contacts are available. Due to the lack of information on the distribution of this device, the MHRA is publishing this alert as a precautionary notice.
  • Société-mère du fabricant (2017)
    ReVision Optics Inc.
  • Source
    MHRA