| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-01042-1 |
| Product Name/Description |
Haag-Streit International -Tonometer Measuring Prisms (an ophthalmic device used to measure eye ocular pressure/tension).
Multiple product codes
All lot/batch numbers
ARTG Number: 158059 |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
6/11/2012 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer, Haag-Streit International, has updated instructions for use (IFU) for ‘Cleaning, Disinfection and Storage of Tonometer Measuring Prisms’ (Product Code: HS-7220316) along with the amended ‘List of Suitable Disinfectants’. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Device Technologies have provided an update to the Instructions for Use (IFU). |
| Contact Information |
1800 429 551 - Device Technologies Regulatory Affairs |