Profile: FCI Ophthalmics concentrates in ophthalmic surgical devices. Our products include retina, cataract, lid repair, orbital implants, lacrimal stents & tubes, and dry products. The orbital implant products offers Bioceramic orbital implants, sphere introducers, disposable sizers, and other ophthalmic surgical devices. The bioceramic orbital implant includes porous, strong, rapid & complete fibrovassularization, light weight, easy to insert, and low exposure rate.Our eyejet is a preloaded capsular tension ring on a disposable injector for cataract surgery. Our ProLong™ absorbable long term plug provides relief from short term dry eye conditions.
The company was founded in 1996, has revenues of USD 1-5 Million and is ISO 9002, CE certified.
FDA Registration Number: 1225124
• Measuring Gauge (FDA Code: JYJ / 874.4420) |
• Microsurgical Still Camera (FDA Code: FTH / 878.4160) A surgical camera and accessories is a device intended to be used to record operative procedures. |
• Microsurgical Television Camera without Audio (FDA Code: FWD / 878.4160) |
• Mid-Face Suture Patch |
• Mid-Face Sutures |
• Mini-Lacrimal Probes |
• Non-Sterile Plugs |
• Ocular Marker (FDA Code: HMR / 886.4570) An ophthalmic surgical marker is a device intended to mark by use of ink, dye, or indentation the location of ocular or scleral surgical manipulation. |
• Ocular Peg (FDA Code: MQU / 886.3320) An eye sphere implant is a device intended to be implanted in the eyeball to occupy space following the removal of the contents of the eyeball with the sclera left intact. |
• Ophthalmic Aspiration Cannula (FDA Code: HMX / 886.4350) A manual ophthalmic surgical instrument is a nonpowered, handheld device intended to aid or perform ophthalmic surgical procedures. This generic type of device includes the manual corneal burr, ophthalmic caliper, ophthalmic cannula, eyelid clamp, ophthalmic muscle clamp, iris retractor clip, orbital compressor, ophthalmic curette, cystotome, orbital depressor, lachrymal dilator, erisophake, expressor, ophthalmic forcep, ophthalmic hook, sphere introducer, ophthalmic knife, ophthalmic suturing needle, lachrymal probe, trabeculotomy probe, cornea-sclera punch, ophthalmic retractor, ophthalmic ring (Flieringa), lachrymal sac rongeur, ophthalmic scissors, enucleating snare, ophthalmic spatula, ophthalmic specula, ophthalmic spoon, ophthalmic spud, trabeculotome or ophthalmic manual trephine. |
• Ophthalmic Cannula (FDA Code: HMX / 886.4350) |
• Ophthalmic Excimer Laser System (FDA Code: LZS) |
• Ophthalmic Forceps (FDA Code: HNR / 886.4350) |
• Ophthalmic Hook (FDA Code: HNQ / 886.4350) |
• Ophthalmic Image Management System (FDA Code: NFJ / 892.2050) A picture archiving and communications system is a device that provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images. Its hardware components may include workstations, digitizers, communications devices, computers, video monitors, magnetic, optical disk, or other digital data storage devices, and hardcopy devices. The software components may provide functions for performing operations related to image manipulation, enhancement, compression or quantification. |
• Ophthalmic Images Communications Device (FDA Code: NFG / 892.2020) A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, interfaces, and a communications protocol. |
• Ophthalmic Images Storage Device (FDA Code: NFF / 892.2010) A medical image storage device is a device that provides electronic storage and retrieval functions for medical images. Examples include devices employing magnetic and optical discs, magnetic tape, and digital memory. |
• Ophthalmic Knife (FDA Code: HNN / 886.4350) |
• Ophthalmic Lasers (FDA Code: HQF / 886.4390) An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam. |
• Ophthalmic Refractometer (FDA Code: HKO / 886.1760) An ophthalmic refractometer is an automatic AC-powered device that consists of a fixation system, a measurement and recording system, and an alignment system intended to measure the refractive power of the eye by measuring light reflexes from the retina. |
• Ophthalmic Retractor (FDA Code: HNI / 886.4350) |
• Ophthalmic Speculum (FDA Code: HNC / 886.4350) |
• Ophthalmics Silicone Orbital Implants |
• Ophthalmics Symblepharon Rings |
• Optical Coherence Tomography (FDA Code: OBO / 886.1570) An ophthalmoscope is an AC-powered or battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye. |
• Optical Coherence Tomography (OCT) (FDA Code: OBO / 886.1570) |
• Orbital Procedures, Evisceration Scoops |
• Orbital Procedures, Titanium Plating Systems |
• Photodynamic Therapy Laser System (FDA Code: MVF) |
• Polarisation-sensitive optical coherence tomography |
• Powered Surgical Laser Instrument (FDA Code: GEX / 878.4810) (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide. |
• Pre-Operative Testing, Tear Volume Testing |
• Probes, Hooks and Forceps |
• PTFE Scleral Buckling Implants |
• Ptosis Crutch (FDA Code: HJZ / 886.5600) A ptosis crutch is a device intended to be mounted on the spectacles of a patient who has ptosis (drooping of the upper eyelid as a result of faulty development or paralysis) to hold the upper eyelid open. |
• Ptosis Slings |
• Punctal Dilators |
• Punctal Gauges |
• Punctum Plug (FDA Code: LZU) |
• Punctum Plugs (Punctal Plugs) |
• Pupil Dilator Injector |
• Pupillometers (Pupilometers) |
• Radiological Digital Image Communication System (FDA Code: LMD / 892.2020) |
• Radiological Digital Image Storage Device (FDA Code: LMB / 892.2010) |
• Refractive Surgery, Pupillometers |
• Retinal Implant (Prosthesis, Intraocular, Lens, Eye) |
• Self-Retaining Bicanaliculus Intubation Set |
• Silicone Orbital Implants |
• Silicone Punctum Plugs |
• Small eyelid implants |