Events

Alerte De Sécurité sur One-Piece Intraocular Lenses

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Hoya Corporation.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2013-02-22
  • Date de publication de l'événement
    2013-02-22
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130222a.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: hoya one-piece intraocular lenses medical device manufacturer, hoya corporation issued a medical device safety alert concerning hoya one-piece intraocular lenses (iol). the affected models are: ny-60 (hoya af-1 imics1) 311 (hoya af-1 toric) 250 and 251 (hoya isert) 351 (hoya isert toric) last month, hoya surgical optics announced a voluntary suspension of shipment of five of their products while they investigated reports of higher than expected rates of inflammation and/or endophthalmitis from doctors using ny-60, isert 250, and isert 251 iols in a few countries. an extensive review of manufacturing process revealed that some products had trace residual foreign particulates on them. the manufacturer has been unable to definitively determine if they were linked to the adverse events but the potential may exist. although no adverse events have been reported with the toric lenses, they were included in the recall because they follow a similar manufacturing process. the manufacturer clarified that no other hoya iols, in particular no three-piece iols, are affected by this recall. according to the manufacturer, this issue may lead to post-operative inflammation and/or endophthalmitis. however, there is no evidence, and no reports of any new cases of inflammation and or endophthalmitis associated with the iols that have been implanted for six months or longer. product recall is ongoing. furthermore, for any patient already implanted with one of the lenses included in this recall, hoya recommends following the patient for three to six months post-operatively to monitor for the possible onset of ocular inflammation. according to the local supplier, hong kong medical supplies ltd., the affected products have been distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 22 february 2013.

Device

One-Piece Intraocular Lenses
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: HOYA One-Piece Intraocular Lenses
  • Manufacturer
    Hoya Corporation

Manufacturer

Hoya Corporation