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
• smaller punctum plugs |
• Sphere Introducer (FDA Code: HNP / 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. |
• Sterile Surgical Drapes (FDA Code: KKX / 878.4370) A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy. |
• Surgical Camera and Accessories (FDA Code: KQM / 878.4160) A surgical camera and accessories is a device intended to be used to record operative procedures. |
• Surgical Drapes (FDA Code: KKX / 878.4370) |
• Surgical Drapes & Packs (FDA Code: KKX / 878.4370) |
• Surgical Microscopes (FDA Code: EPT / 878.4700) A surgical microscope and accessories is an AC-powered device intended for use during surgery to provide a magnified view of the surgical field. |
• Surgical Ophthalmic Cannula (FDA Code: HMX / 886.4350) |
• Symblepharon Rings |
• Tear Saver Plugs |
• Tear Volume Testing |
• Therapeutic X-Ray System (FDA Code: JAD / 892.5900) An x-ray radiation therapy system is a device intended to produce and control x-rays used for radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories. |
• Three-dimensional optical coherence tomography |
• Titanium Plating Systems |
• Transnasal Lacrimal Stents |
• Ultrasonic Puls-Echo Scanner (FDA Code: IYO / 892.1560) An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories. |
• Upper Eyelid Implants |
• Urology Surgical Drapes (FDA Code: KKX / 878.4370) |
• Vitreoretinal Implants |
• Wright Needles |