Slimplant PMMA LENS ETO Sterilized

Slimplant PMMA lenses are intended to be used for primary implantation, at the discretion of the surgeon, for the visual correction of patients suffering from aphakia.

Description

An optical implant made from UV absorbing Poly Methyl Matha Acrylate material designed for the replacement of the natural human crystalline lens for the purpose of correcting aphakia.

The lens has been precision lathe cut and fine polished. Lenses are available in various styles, specifications and powers.

Indication
Slimplant PMMA lenses are intended to be used for primary implantation, at the discretion of the surgeon, for the visual correction of patients suffering from aphakia.

Contraindications
Patients with the following may not be suitable:

Axial myopia more than 7 diopters.

Only one eye with potentially good vision.

Endothelial corneal dystrophy.

Complicated cataracts, e.g. congenital cataract, cataract associated with recurrent iritis, essential iritis atrophy, atopic dematitis, etc.

Aged under 18 years.

Previous retinal detachment in either eye.

Previous implantation.

In case of intracapsular cataract extraction methods.

Recurrent anterior or posterior segment inflammation of unknown etiology.

Where the lens may interfere with the ability to observe, diagnose or treat posterior segment disease.

Surgical difficulties at the time of cataract extraction, e.g. persistent bleeding, significant iris damage, uncontrollable positive pressure or significant vitreous prolapsed or loss.

Warning
Do not re-sterilize.

Lenses are not to be placed in direct sun light or temperatures exceeding 40 degree Celsius.

Do not soak in solutions other than balanced salt solution or the equivalent of such.

The safety of the use of the Neodymium-YAG LASER and intra Ocular lenses with UV
absorbing materials has not been established.

The physician is urged to use extreme caution in such cases where a patient with UV absorbing PMMA intraocular lens is treated with a Neodymium-YAG LASER. Only skilled surgeons with experience in either viewing and/or assisting numerous surgical implantations and successfully completed at least one course on PMMA intraocular lens implantation should attempt implantation of these lenses.

Complications
Complications related to intraocular surgery include but are not limited to the following:

Hyphema, Macular Edema, Pupillary Block, Secondary Glaucoma, Gyclitic Membrane,
Vitritis, Endophthalmitis, Retinal Detachment, Persistent Corneal Edema, Persistent Iritis, Lens Dislocation, Infection, Uvetis, Vitreous Loss, Corneal Dystrophy, Pupillary Membrene, Flat anterior chamber, Iris prolapsed, hypopyon.

The long-term effects of PMMA intraocular lens implants have not been determined.
Therefore, physicians should continue to monitor implant patients on a regular basis.

Packing and Directions for Use
Slimplant PMMA intraocular lenses are supplied sterile in a poly propylene container placed in a dry heat sealed TYVEK Pouch. The inner package is terminally sterilzed with ethylene oxide. First, check the expiration date on the box and make sure the lens is still valid. To remove lens, carefully peel open outer pouch in a sterile environment and carefully remove the lens from the plastic container made of poly proylene and place the lens in balanced salt solution in soak until ready to implant.

Storage
Stored AT 5°C TO 40°C. Avoid exposure to high temperature, direct sunlight and water.

Store in a secure location to prevent unwanted damage to the packing material.

How Supplied
SLIMPLANT sterile PMMA Lenses are available in various powers and models. These are supplied in a single dispensing box.

Shelf Life
5 years from the date of manufacture.

Manufactured in India by

Ophthalmic Technology

H1-662, Industrial Area,

Khushkhera – 301707 Rajasthan, India