Profile: Dutch Ophthalmic USA provides ophthalmic surgeons with instruments & equipment designed specifically for the demanding needs of phacoemulsification and vitreoretinal surgery. Our products include surgical system, ophthalmic surgical liquids, anterior disposable instruments, reusable instruments, surgical units, vitreoretinal instruments, and disposable vitreoretinal instruments. Our D.O.R.C. Associate® is an ophthalmic system that integrates a peristaltic and venturi pump, allowing surgeons to independently select either pump mode for phaco or vitrectomy procedures. Our D.O.R.C membrane instruments are designed to provide the vitreoretinal surgeon with an array of instruments for atraumatic dissection of vitreous membraces, and offer vitreoretinal procedures involving membrane removal. Our Eftiar® ophthalmic surgical liquids offers the vitreoretinal surgeon a temporary tamponade for efficient re-attachment of the retina, release of subretinal fluid, dissection of fibro vascular proliferation and controlling retinal bleeding.

The company is ISO 9001:2000, ISO 13485:2003, CE certified.

FDA Registration Number: 1222074

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• Ophthalmic Suturring Needle (FDA Code: HNM / 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 Trocar Cannula (FDA Code: NGY / 886.4350)

• Ophthalmological Endodiathermy Systems

• Orbital Depressor (FDA Code: HNX / 886.4350)

• Phacoemulsification Systems

• Phacofragmentation Unit (FDA Code: HQC / 886.4670) A phacofragmentation system is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.

• Photokeratoscope (FDA Code: HJA / 886.1350) A keratoscope is an AC-powered or battery-powered device intended to measure and evaluate the corneal curvature of the eye. Lines and circles within the keratoscope are used to observe the corneal reflex. This generic type of device includes the photokeratoscope which records corneal curvature by taking photographs of the cornea.

• 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.

• Retinal Forceps

• Retinal Instruments

• Retinal Scissors

• Reusable Aspiration and Injection Needle (FDA Code: GDM / 878.4800) A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892.

• Sclera Marker (FDA Code: HMQ / 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.

• Scleral Depressors

• Self-Opening Iris Scissors

• Stainless Steel Iris Scissors

• Sterile ENT Cutting Block (FDA Code: JXS / 874.3540) A prosthesis modification instrument for ossicular replacement surgery is a device intended for use by a surgeon to construct ossicular replacements. This generic type of device includes the ear, nose, and throat cutting block; wire crimper, wire bending die; wire closure forceps; piston cutting jib; gelfoamTMpunch; wire cutting scissors; and ossicular finger vise.

• Stevens Tenotomy Scissors

• Student Iris Scissors

• Surgical Ophthalmic Cannula (FDA Code: HMX / 886.4350)

• Swiss Diamond Knives

• Titanium Ophthalmic Forceps

• Titanium RETINAL Forceps

• Vertical Microscissors

• Vitrectomy Cutters (FDA Code: MLZ / 886.4150) A vitreous aspiration and cutting instrument is an electrically powered device, which may use ultrasound, intended to remove vitreous matter from the vitreous cavity or remove a crystalline lens.

• Vitrectomy Systems

• Vitreoretinal Illumination Systems

• Vitreoretinal Surgery, Retinal Instruments

• Vitreoretinal Surgery, Vitreoretinal Illumination Systems

• Xenon Illumination System

• Zenoni angled Retinal Forceps