Search Results
Found 1 results
510(k) Data Aggregation
K Number
K143280Device Name
BHV VIVID (etafilcon A) Soft (Hydropholic) Contact Lens
Manufacturer
Date Cleared
2015-04-23
(160 days)
Product Code
Regulation Number
886.5925Why did this record match?
Applicant Name (Manufacturer) :
Brien Holden Vision Pty Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The BHV VIVID (etafilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of distance, intermediate and near vision in presbyopic, phakic or pseudo-phakic persons with non-diseased eyes who can have up to approximately 1.50 diopters (D) of astigmatism.
The BHV VIVID (etafilcon A) Soft (Hydrophilic) Contact Lens helps protect against transmission of harmful UV radiation to the cornea and into the eye.
Eye care practitioners may prescribe the lenses either for single use disposable wear or frequent/planned replacement wear with cleaning, disinfection, and scheduled replacement (see "Wearing Schedule").
When prescribed for single-use disposable wear (see "Wearing Schedule") the BHV VIVID (etafilcon A) Soft (Hydrophilic) Contact Lens is to be discarded after each removal. Therefore no cleaning or disinfection is required. When prescribed for frequent/planned replacement wear the BHV VIVID (etafilcon A) Soft (Hydrophilic) Contact Lens is to be cleaned, rinsed, and disinfected each time the lens is removed. The BHV VIVID (etafilcon A) Soft (Hydrophilic) Contact Lens contact lens is to be discarded after the recommended wearing period as prescribed by the eye care practitioner. When prescribed for frequent/planned replacement wear, the lenses should be disinfected using a chemical disinfection system only (i.e., not heat).
Device Description
The BHV VIVID (etafilcon A) Soft (Hydrophilic) Contact Lens is an extended depth-of-focus (EDOF) contact lens for the daily wear correction of distance, intermediate and near vision in presbyopic persons.
The lens material, etafilcon A. is a random co-polymer of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid (MAA), which were cross-linked with ethylene qlycol dimethacrylate (EGDMA) and 1,1,1 -trimethylolpropane trimethacrylate (TMPTMA) via photo-polymerization. These lenses are tinted blue using color additive Reactive Blue No. 19 to make them more visible for handling. These lenses contain UV blocker, a benzotriazole UV absorbing monomer to block UV radiation. The average transmittance characteristics of theses lenses are less than 5 % in the UVB range of 280-315 nm and less than 30% in the UVA range of 315-380 nm. Lenses are supplied sterile in sealed blister package containing sterile isotonic borate buffered saline solution.
Ask a Question
Ask a specific question about this device
Page 1 of 1