Device Dossier
OPTIVE Fusion Unit dose - Lubricant, eye
Device Dossier for OPTIVE Fusion Unit dose - Lubricant, eye (Lubricant, eye, Class III, sponsor AbbVie). ARTG record, intended purpose, GMDN category —…
- GMDN category: Lubricant, eye
- Sponsor: AbbVie
Intended purpose
Intended to lubricate the surface of the eye(s) to relieve the feeling of dryness, burning, irritation, stinging, foreign body sensation and/or discomfort caused by dry eye disease or environmental factors such as dust, glare, pollen and air pollution.
Functional description
The HA polymer of OPTIVE Fusion UD is highly hydrophilic, allowing it to retain water, and has well known shear-thinning properties. This assists carmellose, favourably influencing the viscoelastic properties of the formulation, giving generally higher viscosity at low shear (between blinks) and decreasing viscosity under increasing shear rates (during blinking). This is designed to result in enhanced on-eye comfort and to reduce side effects such as blurring and stickiness.