Events

Recall of Hoya One-Piece Intraocular Lenses

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Hoya Healthcare Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    14248
  • Event Initiated Date
    2013-02-26
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Designs for Vision NZ Ltd, 52 Chesterton Street, Johnsonville, Wellington
  • Reason
    Higher than expected rates of inflammation and/ or endophthalmitis. an extensive review of manufacturing process revealed that some products had trace residual particulates on them. as a precaution manufactureris immediately initiating a recall.
  • Action
    Product to be returned to supplier

Device

Hoya One-Piece Intraocular Lenses
  • Model / Serial
    Model: NY-60, iSert 250, iSert 251, Toric 311 and iSert Toric 351,, Affected: multiple
  • Manufacturer
    Hoya Healthcare Corporation

Manufacturer

Hoya Healthcare Corporation
  • Manufacturer Parent Company (2017)
    HOYA Corp.
  • Source
    NZMMDSA