| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01467-1 |
| Product Name/Description |
EasySept HYDRO+ (3% hydrogen peroxide) Cleaning & Disinfecting Solution (Contact lens care kit)
Affected Products :
EasySept HYDRO + Duo Pack 480 mL
EasySept HYDRO+ Value Pack 840 mL
Easy Sept HYDRO + Starter Kit 120 mL
All Batches
ARTG Number: 203455 |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
16/11/2016 |
| Responsible Entity |
|
| Reason/Issue |
This recall has been initiated as a precautionary measure based on internal testing that simulated normal product use. There have been occasional occurrences where the residual peroxide remaining in the lens case after neutralisation was above product specification. This could lead to the user experiencing temporary ocular symptoms such as burning/stinging, irritation, and red eye. |
| Recall Action |
Recall |
| Recall Action Instructions |
Pharmacists and optometrists are advised to quarantine affected stock and to return them to the place of purchase for a credit. They are also advised that should a consumer return any stock affected by this issue; please offer them a full refund. Wholesalers are advised to immediately quarantine and destroy all affected/returned stock.
This action has been closed out on the 26/09/2018. |
| Contact Information |
1800 251 150 - iNova Pharmaceuticals Customer Service |