ophthafutur octa & deca

ophthafutur octa & deca are used intraoperatively for surgical maneuvers.

 

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)

 

ophthafutur deca octa syringe vial packshot

THE ISSUE

manufacturing-related impurities

Hvalue >> 10 ppm

perfluorooctane perfluorodecaline Issue

Perfluorooctane and Perfluorodecaline are both liquids 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

multi-step ultra-purification process

Hvalue ≤ 10 ppm

ultra-purified ­perfluorocarbon

our response: ultra-purified ­perfluorocarbon liquids

ophthafutur® octa and deca are 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 10 ppm, 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.

usability of octa & deca

intended use of octa & deca

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.

 

ophthafutur pfcl handling ophthafutur pfcl handling

handling octa & deca

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.

 

ophthafutur high performance polymer syringes

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.

 

ophthafutur designed fingerplate

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.

 

For additional information please consult directions for use.