Ophthafutur Deca

Product SKU: OF-500503
Availability: Out Of Stock

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Item No:  OF-500503
Product Name:  Ophthafutur Deca
Product Type:  Liquid

Product Description:

  • High patient and product safety

 

  • Multi-step proven & tested ultra-purification process

 

  • Safe, biocompatible, sterile, endotoxin-free products

 

  • 3 years shelf life

 

  • Novel high performance polymer syringes (HPPS)


The Issue:

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Perfluorodecaline is a liquid consisting from carbon and fluorine atoms only. For use as a medical device, it is ­essential that no other atoms ­(like Hydrogen: H) are bound in the molecules. Such alterations in the atomic structure can result in very reactive molecules, subsequently leading to tissue inter­action. Incompletely fluorinated molecules can potentially damage the sensitive ­tissues within the eye.

A measure for the purity of a Per­fluorocarbon is the H-Value. The H-value summarizes all impurities which relate to the presence of Hydrogen (H) containing compounds. A whole library of such compounds can be present even in incomplete purified products and each of these compounds can create a severe adverse reaction. Standard procedures of purifying and analytical controls are not sufficient to separate or ­detect the toxic impurities.

Our Answer:

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Ultra-purified perfluorocarbon liquids.
ophthafutur® deca is highly purified by a unique and multi-step process. During the ultra-purification, all potential impurities are removed down to a level of not more than 10ppm, which represents the limit of quanti­fication. The in-process controls are very strict during manufacturing and analytics of  ophthafutur® products. This results in a product which is finally purified to the highest extent.

The purification steps are monitored and the success of the purification process is verified. Final products are only accepted if the H-value is below 10 ppm.

Intended Use:

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Perfluorocarbon liquids (PFCL) are used for intraoperative unfolding and repositioning/fixation of a detached retina. Furthermore, these liquids simplify the removal of luxated lenses and foreign bodies from the vitreous.

Handling:

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PFCL, due to their high density, sink to the bottom of the eye. When applied, the liquid should be slowly injected over the papilla until a small bubble forms.

The tip of the injection cannula should then be kept within the bubble, gently enlarging it.

When removing PFCL, the user should ensure complete removal.

Remnants of PFCL may cause adverse reactions such as inflammation and could lead to inter­actions with subsequently filled silicone oil.

It is not recommended to directly exchange the PFCL with silicone oil to avoid direct contact between the two substances.

Novel High Performance Polymer Syringes (HPPS):
As glass syringes add considerable weight (uncomfortable for the ­surgeon) and PFCL can possibly interact with the lubrication of glass syringes, we introduced a novel filling technology.

Using HPPS syringes avoids contact between the perfluorocarbon liquid and the standard lubrication used in glass syringes.

This measure increases safety and reduces the likelihood of sticky ­effects or emulsification.
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Preloaded syringes offer an ideal solution for the surgeon: They are easy to prepare and use. An ergonomically designed fingerplate was created to aid control and comfort.



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