Hard on bacteria. Soft on eyes.
EasySept disinfects and stores all soft contact lenses, including silicone hydrogels. When used in combination with the catalytic disc EasySept works to disinfect soft contact lenses, removing micro-organisms. After six hours the neutralisation process is completed and the Hydrogen Peroxide solution is completely converted to a preservative free saline solution, and lenses are ready to use. EasySept system contains 3% Hydrogen Peroxide solution, lens case and catalytic disc.
Directions for use:
Sterile and buffered 3% hydrogen peroxide solution with a phosphonic acid stabiliser, sodium chloride and phosphate buffers.
Bausch + Lomb UK is conducting a voluntary recall of EasySept Hydro+® 3% Hydrogen Peroxide Cleaning & Disinfecting Solution in Europe.
Although this voluntary recall represents low risk to the consumer and is unlikely to cause serious health consequences, the company chose to initiate this voluntary action as a precautionary measure as part of its ongoing commitment to quality and customer satisfaction. Additionally, there have been no reports of adverse incidents in relation to this voluntary recall.
The company chose to initiate this voluntary recall based on internal testing that simulated normal product use. Testing showed occasional occurrences where the residual peroxide remaining in the lens case after neutralisation did not meet product specification.
EasySept Hydro+® solution is unlikely to cause serious health consequences. If the residual hydrogen peroxide is above product specification the user of the product could experience temporary symptoms of burning/stinging sensation, irritation and/or red eye.
This voluntary recall from Bausch + Lomb is a customer level recall only and is limited to Europe. The local regulatory body, The Medicines and Healthcare products Regulatory Agency (MHRA) has been notified of this voluntary recall. The EasySept Hydro+® 3% Hydrogen Peroxide Cleaning & Disinfecting Solution is the only product affected in this voluntary recall.
All customers, including eye care professionals and retailers, who have purchased EasySept Hydro+ have been directly contacted to inform them of the appropriate steps to quarantine and return all lots of the EasySept Hydro+® 3% Hydrogen Peroxide Cleaning & Disinfecting Solution to Bausch + Lomb UK.
For any adverse events as a result of using this product, please report it to us directly on 0800 056 3973
For any further media enquiries please contact UKmediaenquiries@bausch.co.uk
VOLUNTARY RECALLED PRODUCT DETAILS Product: EasySept Hydro+® 3% Hydrogen Peroxide Cleaning & Disinfecting Solution Marketed Product Name (all sizes) Formula Code Easysept Hydro+® BL-3100-EZS05
Lot numbers: All Lots
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1. FDA/ISO Stand Alone Procedure for Disinfecting Products of BL-3100-EZS05
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