Presentation

Op’cover is a single dose with 2.2% HPMC, sterile and apyrogenic, intended for protecting the cornea during tests, and different types of ophthalmic or general surgical operations.
A drop placed on the cornea protects the eye from dehydration and prevents abrasions linked to the lack of a lachrymal film during anaesthesia.

corneal-protection-hpmc-opcover

Improves tests with diagnostic lens

The use of Op’cover creates a protective film between cornea and test lens, improves intraocular image definition and maintains the hydration of the cornea.

To improve the tolerance and avoid secondary effects, Op’Cover is sterile and preservative free.

ophthalmic-gonioprism-opcover

Improves ophthalmic surgical procedures

The use of Op’cover allows the doctor to concentrate on his surgical procedure without interruption and without change of focal length to hydrate or request hydration of the cornea from his operational support.

Op’cover improves visualisation of the intraocular structures thanks to its magnifying effect.
The clarity of the cornea remains constant throughout the operation, unlike the gradual opacification of the corneal edges when using an irrigating saline solution.

Protects the cornea during anaesthesia

Under anaesthesia, the reduction in tear production, reduced lysosomal protection as well as disappearance of Bell’s phenomenon, combined with partial palpebral closure, induce rapid dehydration of the cornea and the risk of abrasion of the corneal epithelium.
Op’cover substitutes the lachrymal film during ophthalmic surgery or general surgery under anaesthesia, to avoid corneal dehydration, abrasions or perforations.

ophtalmic surgery on video

General indications

Medical device intended to temporarily form a protective layer onto the eye surface during ophthalmological examination with a lens or surgery (ophthalmic or not). The device is designed to avoid corneal dehydration or irritation while maintaining the cornea optical clarity.

Also usable for IOL cartridge lubrication.

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Instruction for use

hpmc-hypromellose-opcoverLast revised: October 14th 2016
Product Op’Cover®

Intended uses:

Medical device intended to temporarily form a protective layer onto the eye surface during ophthalmological examination with a lens or surgery (ophthalmic or not). The device is designed to avoid corneal dehydration or irritation while maintaining the cornea optical clarity.

Secondary indication:

For lubrication of cartridge in the scope of Intraocular Lens injection into the patient eye. In any case, please refer to Instruction for Use of the cartridge.

Description:

Contains 10 sterile single-use devices of 2 ml of a sterile viscous isotonic and transparent solution without preservatives. Individual pouches guarantee the external sterility of each single-use.

 

Composition:

2.2 % of hypromellose, in phosphate buffer.

Method of administration:

The device should be used only by health professional who is authorized to perform. Take a pouch out from the protective bag then re-close it carefully. Peel open the pouch and drop the single-use container onto the sterile field. In sterile conditions, open the container and hold with opening facing down. Squeeze gently in order to apply an adequate amount of the solution. If necessary, repeat the application, then put down the container back onto the sterile field. The viscous solution can easily be removed by rinsing with saline sterile solution.

Contraindications:

Do not administer to patients who are known to be hypersensitive to one of the components. Do not use after expiration date. If any of the packaging material or single-dose is damaged, or if solution becomes cloudy do not use the device. Once pouch or single-use is opened, the sterility cannot be guaranteed. To avoid any contamination, do not re-use the device, do not preserve it, do not re-sterilize.

Interactions:

The device may modify the effect of drugs administered concomitantly on the eye.

Warnings:

Single-use device. Remove contact lenses before using. Do not make contact with the tip to any surface, since this may contaminate the solution. To avoid epithelial damage, do not touch the cornea with the tip of the container. In case of tingling or irritation, immediately flush the eye with plenty of isotonic sterile solution.

Disposal of waste:

No restriction.

Storage:

At room temperature (15 à 25°C) in the original packaging.

Sterilization method:

Autoclave.

 

CE marking: 2016-08