FCI Ophthalmics,
Western Ophthalmics Corporation
Advanced Visual Instruments, Inc.,
Lactona Corp.
Teller acuity cards are sufficiently sensitive for early detection of deficits in the presence of defects of the entire visual system. The infant is shown a card with the same background brightness. The examiner is hidden behind a viewing case that covers him or her from the front and side. An observation pinhole in the middle of the card permits the examiner to observe only the infants eyes and determine upon which side of the card the infant is fixating. Infants who prefer the striped side have good fixation.
Stereo Optical Co., Inc.,
Chona Surgical Company
(FDA Code:
MLP /
886.34)
Identification. A keratoprosthesis is a device intended to provide a transparent optical pathway through an opacified cornea, either intraoperatively or permanently, in an eye that is not a reasonable candidate for a corneal transplant.
Classification. Class II. The special controls for this device are FDA's:
Ocular Instruments Inc.,
Madhu Instruments
Terrific broth is used with glycerol in cultivating recombinant strains of Escherichia coli. It is a highly enriched medium developed to improve yield in plasmid-bearing E. coli. Recombinant strains have an extended growth phase in the medium. The addition of extra peptone and yeast extract in the medium allows higher plasmid yield per volume. Glycerol is used as the carbohydrate source in this formulation.
Biosource International,
Teknova, Inc.,
Cambrex
Briot-Weco Australia Pty Ltd
Cambrian Medical Inc.,
Medtronic Ophthalmics,
Advanced Meditech International, Inc.
Brinkmann Instruments, Inc,
Boekel Scientific
Thermokeratoplasty is a form of laser eye surgery. It is used to treat astigmatisms and farsightedness. Thermokeratoplasty is a refractive surgical procedure for the correction of hyperopia, which uses selective heating to reshape the cornea. Thermokeratoplasty is an FDA-approved vision correction procedure to correct nearsightedness or hyperopia.
Sunrise Technologies International, Inc.,
Refractec, Inc.
Thicker artificial tears and ointments are suitable for use as a mainstay in the treatment of dry eyes. These are formulated to mimic the composition of natural tears. These eye drops are made of harmless moisturizing substances, which are designed to cover the eyes with an enduring moisturizing film to compensate for the lack of natural tears.
Allergan, Inc,
Thera Tears,
Bio-Logic Aqua Technologies
Rusch Inc.,
Sontec Instruments, Inc.,
Autosuture,
more...
Three-dimensional optical coherence tomography is a non-contact, noninvasive imaging technique used to obtain high resolution cross-sectional images of the retina. It is generally is based on a transversal scanning scheme and combines the imaging modes of a scanning laser ophthalmoscope with the depth sectioning capability of OCT.
Carl Zeiss Meditec, Inc.,
FCI Ophthalmics,
Imalux Corporation,
more...
Rusch Inc.,
Autosuture,
High Class Dental,
more...
Tilt stand magnifiers can be used for right or left hand users and can be tilted front to back to help reduce neck strain. It comes in various magnifications.
Eschenbach Optik of America Inc.,
Lactona Corp.
Timolol ophthalmic solution is a beta- adrenergic blocking agent. It mainly blocks the action of the sympathetic nervous system. It causes a reduction of the intraocular pressure within the eye. This effect is caused by a reduction in the production of the liquid (aqueous humor) within the eye. The reduction in intraocular pressure reduces the risk of damage to the optic nerve and loss of vision in patients with glaucoma.
Allergan, Inc
(FDA Code:
NFD /
886.116)
Identification. A color vision plate illuminator is an AC-powered device that is a lamp intended to properly illuminate color vision testing plates. It may include a filter.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9.
Advanced Digital Eyewear,
Bristol C&D, Inc.,
Hwa Meei Optical Co., Ltd.,
more...
Ciba Vision
Tissue forceps are designed to grasp tissue causing minimal trauma. Many tissue forceps have the appearance of a pair of tweezers. The tip of tissue forceps varies depending on the usage.
Wholesales Surgical Instruments, Inc.,
Cambrian Medical Inc.,
Sontec Instruments, Inc.,
more...
Titanium bayonet forceps provide the balance and precision desired for operating in deep cranial or spinal incisions.
Rusch Inc.,
Autosuture,
High Class Dental,
more...
Titanium bipolar forceps are used where lower instrument weight, non-magnetic and stainless qualities are required. The bipolar forceps jaws close accurately giving the surgeon confidence to carry out precise and delicate work, and the titanium alloy used ensures good wear resistance.
Rusch Inc.,
Sontec Instruments, Inc.,
Autosuture,
more...
Howard Instruments, Inc.,
Medennium, Inc.,
Allergan, Inc,
more...
Pro Orthopedic Devices,
DENOVO Dental Inc.,
Masel,
more...
Mentor Corporation,
Addition Technology Inc.,
Medtronic Xomed Surgical Products, Inc,
more...
Lorenz Surgical,
FCI Ophthalmics,
Stryker,
more...
Rusch Inc.,
Autosuture,
High Class Dental,
more...
Rusch Inc.,
Autosuture,
High Class Dental,
more...
Tobramycin - Ophthalmic ointment is used to treat eye infections. It is an antibiotic (aminoglycoside-type) that works by stopping the growth of bacteria. It is a sterile topical ophthalmic antibiotic formulation prepared specifically for topical therapy of external ophthalmic infections. This medication mainly treats bacterial eye infections.
Akorn, Inc.
(FDA Code:
HPK /
886.193)
Identification. A tonometer and accessories is a manual device intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea). Accessories for the device may include a tonometer calibrator or a tonograph recording system. The device is intended for use in the diagnosis of glaucoma.
Classification. Class II.
Falck Medical, Inc,
ODC Ophthalmic Development Co. Ag
(FDA Code:
HLA /
886.193)
Identification. A tonometer and accessories is a manual device intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea). Accessories for the device may include a tonometer calibrator or a tonograph recording system. The device is intended for use in the diagnosis of glaucoma.
Classification. Class II.
Kowa Co., Ltd.,
Medton E.K.,
Dimeda Instrumente Gmbh
(FDA Code:
HKZ /
886.194)
Identification. A tonometer sterilizer is an AC-powered device intended to heat sterilize a tonometer (a device used to measure intraocular pressure).
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 886.9.
Tekyard LLC,
Numa Corp.,
Essential Spa Tools, Llc,
more...
AZReam, Inc.,
Veatch Ophthalmic Instruments,
ProTech Ophthalmics,
more...
Topography is a computer assisted diagnostic tool that creates a three-dimensional map of the surface curvature of the cornea. The cornea is responsible for about 70 percent of the eye's focusing power. An eye with normal vision has an evenly rounded cornea, but if the cornea is too flat, too steep, or unevenly curved, less than perfect vision results. The advantage of corneal topography is its ability to detect irregular conditions invisible to most conventional testing. Corneal topography produces a detailed, visual description of the shape and power of the cornea. This type of analysis provides fine details regarding the condition of the corneal surface. These details are used to diagnose, monitor and treat various eye conditions. They are also used in fitting contact lenses and for planning surgery, including laser vision correction. For laser vision correction the corneal topography map is used in conjunction with other tests to determine exactly how much corneal tissue will be removed to correct vision and with what ablation pattern.
Ophthalmic Instruments, Inc.,
Treasure Coast Ophthalmic,
Optimetrics, Inc.,
more...
Topography based aberrometry system measures every variation of the entire optics of an eye from the cornea, to the retina. It provides data for the corneal aberrations. It derives a curvature map from topographical measurements. It then uses the data to calculate the wavefront error and incorporates it into the ablation profile of the laser. The surgeon can select the laser shot file of a patient from within the laser software.
Wavelight Laser, Inc.
Toric contact lens is a soft or rigid gas permeable (RPG) contact lens made especially for people with astigmatism. It is designed to comfortably fit the unique shape of eye. Toric lenses have two powers in them, created with curvatures at different angles.
Precision Vision, Ltd.,
Johnson & Johnson Vision Care, Inc.,
Ciba Vision,
more...
Rumex International Co.,
Surgistar Inc.
Rumex International Co.,
Stephens Instruments,
Baxter International Inc,
more...
Sontec Instruments, Inc.,
Rumex International Co.,
Altomed Ltd.
(FDA Code:
HMZ /
886.435)
Identification. 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.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9.
Neomedix Corp.,
Ophthalmic Surgical LLC,
Bausch & Lomb Inc.,
more...
(FDA Code:
HNK /
886.435)
Identification. 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.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9.
Medtronic Xomed Surgical Products, Inc,
KLS Martin, L.P.,
Stephens Instruments,
more...
Tracing software captures the frame, data, provided by the high-accuracy of the frame reader. It stores the frame data along with the patient's prescription, including the lenses selection, coatings, tint, and other specifications into the computer and then transfers the order via a telephone line to a central lab. Once all of the information is entered, the operator can send a job one at a time or batch process to the host terminal, or central edging lab.
Topcon America Corporation
GAM Laser, Inc.
Aspen Surgical Products,
Scanlan International,
Justin Scientific Corp.,
more...
FCI Ophthalmics
Carl Zeiss Co., Ltd.
Howard Instruments, Inc.,
Sontec Instruments, Inc.,
Medtronic Ophthalmics,
more...
A trephine is a surgical instrument with a cylindrical blade. It can be of one of several dimensions and designs depending on what it is going to be used for. This may be specially designed for obtaining a cylindrically shaped core of bone that can be used for tests, cutting holes in bones or for cutting out a round piece of the cornea for eye surgery.
Stradis Healthcare, LLC,
Medtronic Ophthalmics,
Surgical Specialties Corporation,
more...
Trial frames are indispensable devices and at least one spare should be available. A very light-weight, simple type can be useful for children. Any frame is constant use needs to be robust and have several useful adjustments, such as angling and depression for near vision, with space for at least three lenses for each eye.
Cambrian Medical Inc.,
Topcon America Corporation,
Richmond Products, Inc.,
more...
Trial lens is a series of cylindrical and spherical lens's used in testing vision. Spectacles are prescribed for a patient after vision has been tested using trial lenses placed in a special empty spectacle frame worn by the patient. It is available in extensive sets so that in combination any power from -20 D to +20 D in steps of 0.25 D or less can be obtained.
Cambrian Medical Inc.,
Precision Vision, Ltd.,
Marco,
more...
Cambrian Medical Inc.,
Precision Vision, Ltd.,
Marco,
more...
Co/op Optical Vision Designs,
Vision-Ease Lens,
Pixel Optics Inc.
