Events

Recall of Occulentis BV - IOL

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

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
    21966
  • Event Initiated Date
    2017-09-13
  • 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: Device Technologies New Zealand, 47 Arrenway Drive, Albany, AUCKLAND 0632
  • Reason
    The manufacturer has indicated that surface calcification could possibly be the result of phosphate remnants originating from a detergent previously used in the cleaning process of the iol. although the cause of iol opacification is multifactorial, remnants could make the iol under certain conditions more prone to opacification.
  • Action
    Product to be returned to supplier

Device

Occulentis BV - IOL
  • Model / Serial
    Model: , Affected: model numbers starting with L-, LU-, LS- expiry date between 2017-01 and 2020-05.
  • Manufacturer
    Oculentis BV

Manufacturer

Oculentis BV