Events

Recall of LENTIS HydroSmart Foldable Intraocular Lenses in Glass Vials IOL

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Device Technologies Australia Pty Ltd.

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
    RC-2014-RN-01322-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-12-18
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01322-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    The manufacturer has received sporadic notifications of postoperative opacification of the lentis hydrosmart inta ocular lenses (iol’s) in glass vials of all implanted hydrosmart iol’s 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 iol’s. 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
    Customers are requested to inspect their stock and quarantine any affected units in preparation for return to Device Technologies. Surgeons are advised that if postoperative opacification is observed to evaluate visual acuity levels and consider surgical IOL replacement if visual acuity is compromised in face of the patient’s individual conditions and needs. Intraocular lens replacement is the only recommended treatment for postoperative calcification of the IOL leading to compromise of visual acuity. In some cases postoperative opacification of the IOL may present bio- microscopic aspects similar to posterior capsule opacification. Practitioners are advised to carefully evaluate each case to determine the exact nature of the cloudiness and avoid YAG laser capsulotomy in patients with an opacificied IOL since this procedure may affect the IOL replacement if needed in the future. Please see http://www.tga.gov.au/alert/lentis-hydrosmart-intraocular-lenses-supplied-glass-vials . This action has been closed-out on 4/08/2016.

Device

LENTIS HydroSmart Foldable Intraocular Lenses in Glass Vials IOL
  • Model / Serial
    LENTIS HydroSmart Foldable Intraocular Lenses in Glass Vials IOL Model Numbers: All starting with L-, LU-, or LS- Serial Numbers: All starting with 20000 ARTG Number: 192478(All Oculentis IOL models packaged in a blister are not affected by this recall action.)
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd