Foldable  Capsular Vitreous Body (FCVB)  Introduction

FCVB, the first international eyeball-saving artificial organ can mimic the structure and function of the vitreous body of the human eye to a subtle level and can stay in eyes for a long time.

FVCB has been clinically applied in 200+ hospitals successful in the world, saving 2500+ patients with severe ocular trauma and oil-dependent eyes from the pain of of eyeball removal. Obtained 22 patents in China, the United States, Russia, Australia, Japan ect., FCVB has been carried out clinical application successfully in United Kingdom, Netherlands, Poland, Belgium, Greece, Russia, Australia, Turkey, Pakistan with CFDA , CE, TGA ,ISO13485 certificates.

FCVB Design Principles

Foldable Capsular Vitreous Body(FCVB) is made from Medical grade polymer (FDA registered material) and contains a vitreous-like capsule, drain tube and drain valve. The silicone oil will be injected into the capsule via a drain valve to support the retina and eyeball.

FCVB Indications

Based on preliminary clinical trials, the indications approved by CFDA are as follows:

1. 18 to 65 years old, male or female;
2. Eye vision<0.05;
3. The axial length of the surgical eye is 16 to 28 mm;
4. The existing vitreous substitute cannot be used for treatment (unilateral eye) (any of the following conditions is sufficient):  (a). Severe unilateral penetrating injury or penetrating injury, complex retinal and/or choroidal detachment due to retinal rupture, retinal choroidal hemorrhage, etc.;(b).Severe unilateral rupture of the eyeball, resulting in retinal and/or choroidal defects.  (c).Large posterior scleral laceration of unilateral eyeball, which cannot be repaired;  (d).Long-term filling of silicone oil cannot be removed, and retinal reattachment is incomplete;   (e).After two or more retinal detachment surgeries and silicone oil packing, the retina is detached again after silicone oil removal.

The Main Advantages of FCVB

FCVB is a Long-term intraocular filler that can save the patient’s eyeball without implantation of a prosthetic eye.

Clinical Value of FCVB

1. Maintain space for posterior chamber.
2. 360-degree support for the shape of retina and eyeball.
3. Avoid emulsification and displacement of silicone oil.
4. Health & economics analysis.

FCVB Implantation Method

1. Minimally invasive incision.
2. FCVB is implanted by aimplanter into the eye.
3. Silicone oil was injected from the drainage valve to restore intraocular pressure and support the retina.
4. The drainage valve is fixed under the conjunctiva.

Note: Please refer to the instruction manual for contraindications or precautions.