Profile: Alcon Manufacturing, Ltd. is a provider of eye care products. We develop, manufacture and market surgical equipment & devices, pharmaceutical eye drops & consumer vision care products to treat eye diseases and disorders. Our broad range of products represents the strongest portfolio in the eye care industry. We provide advanced treatment for cataract,and refractive disorders such as myopia, hyperopia and astigmatism. We specialize in eye care pharmaceuticals. We continue to forge the path to the most advanced treatment of glaucoma, eye infections, inflammation and allergies. We also focus on sight-threatening diseases such as age-related macular degeneration and diabetic retinopathy. Our products also include the most recent advances in artificial tears and ocular nutrition.
FDA Registration Number: 2523835
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• Non-Invasive Tubing (FDA Code: GAZ / 880.6740) A vacuum-powered body fluid suction apparatus is a device used to aspirate, remove, or sample body fluids. The device is powered by an external source of vacuum. This generic type of device includes vacuum regulators, vacuum collection bottles, suction catheters and tips, connecting flexible aspirating tubes, rigid suction tips, specimen traps, noninvasive tubing, and suction regulators (with gauge). |
• Ocular Surgery Irrigation Device (FDA Code: KYG / 886.4360) An ocular surgery irrigation device is a device intended to be suspended over the ocular area during ophthalmic surgery to deliver continuous, controlled irrigation to the surgical field. |
• Ophthalmic Aberrometer (FDA Code: NCF / 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 AC-Powered Operating Microscope and Accessories (FDA Code: HRM / 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. |
• 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 Eye Shield (FDA Code: HOY / 886.4750) An ophthalmic eye shield is a device that consists of a plastic or aluminum eye covering intended to protect the eye or retain dressing materials in place. |
• Ophthalmic Forceps (FDA Code: HNR / 886.4350) |
• 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 Non-Absorbable Suture (FDA Code: HMN) |
• Ophthalmic Patient Drape (FDA Code: HMT / 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. |
• Ophthalmic Sponge (FDA Code: HOZ / 886.4790) An ophthalmic sponge is a device that is an absorbant sponge, pad, or spear made of folded gauze, cotton, cellulose, or other material intended to absorb fluids from the operative field in ophthalmic surgery. |
• Ophthalmic Trocar Cannula (FDA Code: NGY / 886.4350) |
• Phacoemulsification Surgery, Intraocular Lens Manipulators |
• Phacoemulsification/fragmentation Fluidic (FDA Code: MUS / 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. |
• Phacofragmentation Unit (FDA Code: HQC / 886.4670) |
• Piston Syringe (FDA Code: FMF / 880.5860) A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body. |
• PMMA Intraocular Lenses |
• Polyamide Synthetic Non-Absorbable Suture (FDA Code: GAR / 878.5020) Nonabsorbable polyamide surgical suture is a nonabsorbable, sterile, flexible thread prepared from long-chain aliphatic polymers Nylon 6 and Nylon 6,6 and is indicated for use in soft tissue approximation. The polyamide surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. monograph for nonabsorbable surgical sutures; it may be monofilament or multifilament in form; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached. |
• Polyester Synthetic Non-Absorbable Suture (FDA Code: GAS / 878.5000) Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached. |
• Polyglycolic Acid Synthetic Absorbable Suture (FDA Code: GAM / 878.4493) An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percentl-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. "Monograph for Absorbable Surgical Sutures;" it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved color additive. Also, the suture may be provided with or without a standard needle attached. |
• Polymethylmethacrylate Contact Lens (FDA Code: HPX) |
• Polypropylene Synthetic Non-Absorbable Suture (FDA Code: GAW / 878.5010) Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation. The polypropylene surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be undyed or dyed with an FDA approved color additive; and the suture may be provided with or without a standard needle attached. |
• Polyvinyl Acetal Posterior Capsular Polishing Ophthalmic Cannula (FDA Code: MXY / 886.4350) |
• 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. |
• Rigid Gas-Permeable Contact Lens (FDA Code: MRC / 886.5918) A rigid gas permeable contact lens care product is a device intended for use in the cleaning, conditioning, rinsing, lubricating/rewetting, or storing of a rigid gas permeable contact lens. This includes all solutions and tablets used together with rigid gas permeable contact lenses. |
• Schirmer Strips (FDA Code: KYD / 886.1800) A Schirmer strip is a device made of filter paper or similar material intended to be inserted under a patient's lower eyelid to stimulate and evaluate formation of tears. |
• Scleral Plug (FDA Code: LXP) |
• Scleral Plug Forceps |
• Silk Non-Absorbable Suture (FDA Code: GAP / 878.5030) Natural nonabsorbable silk surgical suture is a nonabsorbable, sterile, flexible multifilament thread composed of an organic protein called fibroin. This protein is derived from the domesticated speciesBombyx mori (B. mori ) of the familyBombycidae. Natural nonabsorbable silk surgical suture is indicated for use in soft tissue approximation. Natural nonabsorbable silk surgical suture meets the United States Pharmacopeia (U.S.P.) monograph requirements for Nonabsorbable Surgical Suture (class I). Natural nonabsorbable silk surgical suture may be braided or twisted; it may be provided uncoated or coated; and it may be undyed or dyed with an FDA listed color additive. |
• Single Piece Intraocular Lenses |
• Soft Lens Accessories (FDA Code: LPN / 886.5928) A soft (hydrophilic) contact lens care product is a device intended for use in the cleaning, rinsing, disinfecting, lubricating/rewetting, or storing of a soft (hydrophilic) contact lens. This includes all solutions and tablets used together with soft (hydrophilic) contact lenses and heat disinfecting units intended to disinfect a soft (hydrophilic) contact lens by means of heat. |
• Surgical Field Fiberoptic Illuminator (FDA Code: HBI / 878.4580) A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient. |
• Surgical Ophthalmic Cannula (FDA Code: HMX / 886.4350) |
• Titanium Intraocular Lens Injectors |
• Titanium Ophthalmic Forceps |
• 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. |
• 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. |