Events

Recall of Viscocel and Viscocel Plus (Hydomethylpropcellulose) 2% Prefilled Syringes 1.5mL and 2.0mL

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Boucher & Muir 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-2013-RN-01262-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-12-06
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01262-1
  • 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
    Inspections findings by the fda noted deficiencies in the quality system regulations for medical device manufacturers relating to sterility and biocompatibility that may result in the release of contaminated products. no injuries have been reported for viscocel, however several cases of endophthalmitis reported to a related viscoelastic product in 2011 manufactured at the same facilities.
  • Action
    Boucher & Muir is advising users to quarantine all units of the affected batches. Boucher & Muir is recovering affected stock and a credit note issued.

Device

Viscocel and Viscocel Plus (Hydomethylpropcellulose) 2% Prefilled Syringes 1.5mL and 2.0mL
  • Model / Serial
    Viscocel and Viscocel Plus (Hydomethylpropcellulose) 2% Prefilled Syringes 1.5mL and 2.0mLProduct Codes: AusVIS15, AusVIS20Batch Numbers: 13D02 (expiry 04/2015), 12A13 (expiry 01/2015), 12J08 (expiry 10/2014), 13B18 (expiry 02/2015), 12J02 (expiry 10/2014), 12G16 (expiry 07/2014), 12I04 (expiry 09/2014) and 12H20 (expiry 08/2014)Manufactured from September 01, 2011 to September 19, 2013ARTG Number: 132648
  • Product Classification
    Ophthalmic Devices
  • Manufacturer
    Boucher & Muir Pty Ltd

Manufacturer

Boucher & Muir Pty Ltd