Events

Recall of Oculentis LENTIS HydroSmart foldable intraocular lens

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

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
    17876
  • Event Initiated Date
    2014-12-24
  • 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
    Oculentis gmbh has received sporadic notifications of postoperative opacification of the lentis® hydrosmart iols in glass vials, resulting in a reported occurrence rate of 0.011% of all implanted hydrosmart iols since 2006., analysis suggests a possible interaction between phosphate crystals originating from the hydration process of the iol material and the fluctuating, batch related presence of silicone residues on some iols. such residues may potentially change the iol surface properties, making it under certain medical conditions more prone to deposition of calcium phosphate from the aqueous humor in predisposed patients. these deposits may compromise the optical transparency of the iol, potentially leading to a reduction in the patient's visual acuity.
  • Action
    Product to be returned to supplier

Device

Oculentis LENTIS HydroSmart foldable intraocular lens
  • Model / Serial
    Model: All IOL models starting with L-, LU-, or LS-, Affected: Serial numbers starting with 20000
  • Manufacturer
    Oculentis GmbH

Manufacturer

Oculentis GmbH