Search Results

Alcon 27GA Chandelier The 27GA Chandelier is indicated for use during posterior segment ophthalmic surgery. Alcon 27+ DS Wide Angle Endoilluminator The 27+DS Wide-Angle Endoilluminator is indicated for use during posterior segment ophthalmic surgery. Alcon 27+ DS Endoilluminator The 27 + DS Endoilluminator is indicated for use during posterior segment ophthalmic surgery.

As part of this premarket notification Alcon presents three new endoilluminators, compatible with the UNITY VCS device cleared in K233876 (clearance date: June 21, 2024). Alcon 27GA Chandelier: The Alcon 27GA Chandelier provides a hands-free wide field of illumination for vitreoretinal procedures. The distal end of the device incorporates a short, tapered fiber optic to provide wide angle illumination projected from a pars plana position of the eye. The distal end consists of a tapered fiber, which is inserted into the eye through the Alcon 27GA entry system. The fiber is malleable so the physician can shape it to form a stable service loop, position the tip, and minimize interference with the lid speculum. Alcon 27+ DS Wide Angle Endoilluminator: The Alcon 27+ DS WA Endoilluminator offers wide-angle illumination, featuring a sapphire lens at the distal end of the probe. This design ensures consistent, low-glare illumination across a broad field of view. Additionally, it incorporates a Dynamic Stiffener (DS) element-a retractable stiffener designed to minimize needle deflection at the proximal end of the stainless steel cannula. as opposed to the fixed stiffener used in previous models. Alcon 27+ DS Endoilluminator: The Alcon 27+ DS Endoilluminator transmits light energy into the eye and incorporates a DS element at the proximal end of the stainless-steel cannula.

The Midfield Light Pipe is a disposable microsurgical instrument used to conduct a field of light to the posterior seqment of the eye in order to visualize the internal structures of the eyes during ophthalmic surgery.

The Midfield Light Pipe will be offered in a 23 gauge (GA), 25GA and 27GA size. Each device consists of an ABS handpiece, 304 stainless steel illumination connector, LDPE EVA jacket material, PMMA illumination fiber, 304 stainless steel needle and a PMMA scleral depressor. The Midfield Light Pipe is an external communicating device, in contact with tissue/bone/dentin for a limited duration (<24 hours). The device will be identical to the existing Peregrine 23GA and 25GA Chandelier Illuminator (K151604), except the illumination fiber used in the Midfield will have a higher numerical aperture (NA). The higher NA of the fiber will allow for a wider light field for improved visibility for the surgeon, without compromising illumination intensity ("brightness"). Peregrine will also provide a scleral depressor for use with the Midfield Light Pipe. Transcleral illumination makes use of the scleral depressor for examination of the vitreous base by manipulating and indenting the sclera while illuminating through the sclera. The scleral depressor is only intended to contact the outer surface of the eye (sclera) for a limited duration (<24 hours). The Midfield Light Pipes are comprised of common materials used in ophthalmic devices. The light pipe is mechanical and contains no electrical components. The Midfield Light Pipes only transmit light energy, they do not control the intensity of the light output - this is controlled by the operating system to which it is attached.

The Nova Eye iTrack™ Advance is indicated for fluid infusion or aspiration during surgery. The Nova Eye iTrack™ Advance is indicated for catheterization of Schlemm's Canal to reduce intraocular pressure in adults patients with open-angle glaucoma.

The iTrack™ Advance is a sterile, single-use manual handheld ophthalmic instrument used by ophthalmologists for infusion and aspiration of fluids during ophthalmic surgery and for catheterization and viscodilation of the Schlemm's canal (Canaloplasty) to reduce intraocular pressure in adults with open-angle glaucoma. After catheterization and viscodilation of the entire circumference of Schlemm's canal, the device may also be used to place a tensioning suture within the canal. The iTrack™ Advance has a handpiece preloaded with an illuminated and flexible microcatheter. The addition of the handpiece provides for improved ergonomics and user interface by allowing single handed delivery of the microcatheter into the eye. The actuator on the handpiece is pushed forward slowly and this advances the catheter around the Schlemm's canal the full 360 degrees. By then sliding the actuator on the handpiece back the catheter is withdrawn back into the handpiece and as this takes place the viscoelastic is injected into the canal using the Ophthalmic ViscoInjector. The iTrack™ Advance is manufactured from biocompatible materials, common within the medical device industry, such as stainless steel, nitinol, and thermoplastics such as polycarbonate, Pebax®, and polymethyl methacrylate (PMMA). The device includes a stainlesssteel cannula, a composite microcatheter, and a polymeric manual handpiece. Additionally, the device is used with a single use manually operated infusion pump (the Ophthalmic ViscoInjector™) and the iLumin™ Fiberoptic Illuminator console (cleared separately in K050716 and K062259 and as a kit in iTrack™ 510(k) K080067).

The Nam illumination probe with chopper is used to illuminate with visible spectrum light the intraocular portion of the eye for improved visualization and manipulation during cataract surgery.

This product transmits light through the optical fiber to the inside of the eye to illuminate the intraoperative field of the eyeball. It consists of tube, handle, optical fiber, fiber cloth, and connector.

Adjustable Chandelier Illuminator family of ophthalmic illuminators is for wide angle illumination during ophthalmic surgery.

The 23ga and 25ga Adjustable Chandelier Illuminators are made to work with the Bausch and Lomb surgical system and Bausch and Lomb Valved ESA (Entry Site Alignment) systems (K012435). These devices are to be manufactured with distally located "Infusion Cannulas" that adequately secure themselves within 23ga and 25ga Bausch and Lomb Valved ESA Systems. The 23ga and 25ga Adjustable Chandelier Illuminators consist of a PMMA (Polymethylm-ethacrylate with Flourinated Polymer Cladding) acrylic fiber (for light transmission), white acetal handle assembly with finger slide for adjustability, PTFE (Polytetrafluor-oethylene) jacket (for fiber) and Stellaris style light connector to fit into the Bausch and Lomb Stellaris PC Vision Enhancement System (K133486). The 23ga and 25ga Adjustable Chandelier Illuminators are to be provided sterile to the user, is a single-use device and is packaged in double Tyvek-to-poly pouches to facilitate introduction to the sterile environment. These provide illumination for eye surgery.

The intended use of the device is to illuminate the eye during anterior and posterior vitreoretinal surgery.

The PHOTON EX is a table-top, xenon lamp lightsource used for intraocular illumination during vitreoretinal surgery. The lightsource employs two channels from a single lamp. The channels terminate with entry ports on the unit's front panel. Each channel has a dedicated filter wheel; the filter wheels include the following band pass filters with an upper cut-off at 650 nm and lower cut-offs at 435nm, 475nm, 475nm, and 515nm respectively. The user inputs are controlled by membrane switches on the front panel.

The iScience Interventional Canaloplasty Microcatheter is indicated for fluid infusion and aspiration during surgery. The iScience Interventional Canaloplasty Microcatheter is indicated for catheterization and viscodilation of Schlemm's canal to reduce intraocular pressure in adult patients with open angle glaucoma.

The iScience Interventional Canaloplasty Microcatheter is a flexible microcatheter designed to allow atraumatic catheterization of spaces in the eye for infusion and aspiration of fluids during surgery. The device allows catheterization and viscodilation of Schlemm's canal to reduce intraocular pressure in adult patients with open angle glaucoma. The microcatheter incorporates an optical fiber to allow transmission of light to the microcatheter tip for surgical illumination and guidance. The device is provided sterile and is intended for single use.

The Xenon BrightStar Illumination System is intended to provide intraocular illumination in vitreoretinal surgery.

The Xenon BrightStar Illumination System consists of the Illumination Unit and accessories. The Illumination Unit uses a Xenon Short Arc Lamp and utilizes two internal focusing systems to focus the light into the end of an optical fiber of two individually controlled ports. Both ports can be individually controlled by choice of an UV cut-off filter and a light intensity setting. Accessories trother system include single use and reusable fiber optic probes, fibers and micro instruments which are delivered sterile or require sterilization prior to use.

The iScience Surgical Fiberoptic Illuminator is indicated for illumination during anterior and posterior segment ophthalmic surgery.

The iScience Surgical Fiberoptic Illuminator (FI) is a portable light source intended to provide illumination during anterior and posterior segment ophthalmic surger. It is designed to be used only with the iScience Surgical iTrack Ophthalmic Microcannula to illum nate tissues during advancement into intraocular structures of the anterior and posterior segment. The FI consists of a splash proof sheet metal enclosure with panel mounted rocker switches for operational control, and a custom light output connector. The FI houses a laster dionel illumination source, and is specific for the iScience Surgical iTrack Ophthalmic Microcannula. The FI is not intended to be sterilized or placed in a sterile enclosure. The FI has a custom designed light output connector that contains two redundant safety interlock switches. These switches, in conjunction with electronic circuitry in the Fly ensure that laser light can only emanate from the laser aperture when an iScience Surgical iTrack Ophthalmic Microcannula is installed in the connector. The interlock switches independently detect the proper insertion of the iScience Surgical iTrack Ophthalmic Microoannulaipe into thre connector, ensuring that the microcannula is fully engaged and retained in the connector before laser output is enabled.

The iScience Surgical Ophthalmic Microcannula is indicated for fluid infusion and aspiration, as well as illumination, during surgery.

The iScience Surgical Ophthalmic Microcannula, or iTRACK, is a flexible microcannula designed to allow atraumatic cannulation of spaces in the eye such as the anterior chamber and posterior segment, for infusion and aspiration of fluids during surgery, including saline and viscoelastics. The microcannula incorporates an optical fiber to allow transmission of light to the microcannula tip for surgical illumination and guidance.