Events

Recall of Hydrophilic Acrylic Single Use lntraocular Lens system packs

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Kevin Grundy (IBD) 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-2015-RN-00180-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2015-03-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00180-1
  • 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
    Rayner through kevin grundy (ibd) pty ltd is informing the customers that certain products released to market contain an injector (individually wrapped within the product carton) that has a slightly shorter expiry date than the expiry date as shown on the outer carton. the affected lots may have an expiry date (on the outer carton) of november 2019, december 2019 or january 2020), the individually wrapped injector has its own expiry date marked on the tyvek lid. the expiry date of the associated injectors is around one month prior to that shown on the outer carton.There is no immediate issue associated with the use of the product. the affected product will not expire at least for four year and eight months.
  • Action
    Kevin Grundy (IBD) Pty Ltd (for Rayner) is requesting the customers to return all the affected units. Rayner Intraocular Lenses Limited offers free replacementfor the products that are not intended to be used in the short term.

Device

Hydrophilic Acrylic Single Use lntraocular Lens system packs
  • Model / Serial
    Hydrophilic Acrylic Single Use lntraocular Lens system packsProduct Model No.: 623TBatch Numbers: 65190, 64525, 64529, 64720, 65224,65224, 65251, 65544 ARTG Number 100926Product Model No.: 653LBatch Number:65122ARTG Number:1752621
  • Manufacturer
    Kevin Grundy (IBD) Pty Ltd

Manufacturer

Kevin Grundy (IBD) Pty Ltd