Safety Alert Or Field Safety Notices for Goldmann applanation tonometer prism

Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.

Damage to the tonometer prism due to the use of inappropriate disinfectants may result in corneal irritation.The manufacturer has received three reports of damage to tonometer prisms caused by disinfectants not recommended for use with this device.Once damaged, the tonometer prism may take up some of the disinfectant solution during the cleaning process. This solution may then come into contact with the patient’s eye during the measuring procedure resulting in an increased risk of irritation to, or erosion of, the cornea.As a result of these reports, Haag-Streit issued a Field Safety Notice (FSN) in October 2008 to all customers, (published on the MHRA website). Included in the FSN is a field test for clinicians to check the tonometer prism for cracks and scratches. Any tonometer prism that shows cracks or scratches should not be used but should instead be returned to the manufacturer.A list of recommended disinfectants can be found on the manufacturer’s website (www.haag-streit.com).The MHRA has published this Medical Device Alert to support the manufacturer’s actions due to a poor response to the FSN.