DESCRIPTION
APPAVISC PFS (Hydroxypropyl Methylcellulose Ophthalmic Solution USP) is sterile, a pyrogen free clear &transparent viscous solution of highly purified HPMC. The chemical name of active ingredient is Cellulose 2- Hydroxypropyl Methyl Ether. Each mL contains: Hydroxypropyl Methylcellulose USP 2% w/v& Sterile isotonic base q.s.
MODE OF ACTION (Mechanism of Action)
HPMC consists of large macromolecules that exert a protective effect on ocular tissue during surgical procedures. It limits the mechanical damage from invasive procedures by separating and lubricating tissues.The HPMC also shows to decrease the damage of corneal endothelial cell loss during surgery. It is routinely used as an adjuvant in cataract surgery, IOL, corneal transplantation and surgery of glaucoma. HPMC goes well with the lens and other corneal surfaces because of its low contact angle.
INTENDED USE
• APPAVISC PFS is indicated as a surgical aid (medical device) in anterior segment surgical procedures involving the anterior chamber of the eye, including extraction of the lens and insertion of intraocular lenses. It maintains the depth of the anterior chamber during the whole surgical procedure and permits greater operative precision without the risk of damaging the endothelium of the cornea or other intraocular tissues.
CONTRAINDICATIONS
APPAVISC PFS is contraindicated in patients with glaucoma and Contraindicated in patients with known history hypersensitivity to its ingredients.
WARNING
Do not use if the solution becomes dark brown or any floating particles are observed If pouch is damaged should not be reused. In-case of any serious accident in relation to the device, inform to the manufacturer and to the regulatory authority.
PRECAUTIONS
GENERAL Overfilling of APPAVISCPFS in anterior chamber should be avoided as it may raise IOP & cause glaucoma. APPAVISCPFS is to be removed out of eye after the surgery by irrigation or aspiration. IOP should be monitored, especially after the end of surgery. If IOP is recorded, the appropriate therapy should be employed. APPAVISC PFS should be introduced in anterior chamber such that no air bubble should be trapped in HPMC. Syringe and cannula once used should be discarded.