VISION
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A RECORD OF OPHTHALMIC ACHIEVEMENT

For more than three decades, we have been innovating in the ophthalmic industry. Now, we look to the future as we continue to carve out a path of sight-enhancing and vision-restoring innovation.

From developing the first American-made phacoemulsification system to introducing a broad range of custom LASIK capabilities — including the first femtosecond laser for LASIK flap creation — and contact lens care solutions, we have spent the last 30 years pushing the boundaries of vision surgery and ophthalmology, bringing improved vision to the patients and physicians who use our products.

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FOOTNOTES

*Based on publicly available sources on the Stellaris Vision Enhancement System and Infiniti Vision System in the U.S. as of April, 2016.

REFERENCES

  1. Trokel, SL. Commercial ophthalmic YAG lasers. YAG Laser Ophthalmic Microsurgery. ed. Trokel, SL. 181-192, Appleton-Century-Crofts, Norwalk, Connecticut, 1983.

INDICATIONS AND IMPORTANT SAFETY INFORMATION

FOR TECNIS® MONOFOCAL 1-PIECE IOL

Rx Only

INDICATIONS

TECNIS® 1-Piece Lenses are indicated for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extra capsular cataract extraction. These devices are intended to be placed in the capsular bag.

WARNINGS

Physicians considering lens implantation should weigh the potential risk/benefit ratio for any conditions described in the TECNIS® 1-Piece IOL Directions for Use that could increase complications or impact patient outcomes.

See Full Indications and Important Safety Information for the TECNIS® Monofocal 1-Piece IOL.

FOR THE TECNIS® TORIC 1-PIECE IOL

Rx Only

INDICATIONS

The TECNIS® Toric 1-Piece Posterior Chamber Lens is indicated for the visual correction of aphakia and pre-existing corneal astigmatism of one diopter or greater in adult patients with or without presbyopia in whom a cataractous lens has been removed by phacoemulsification and who desire improved uncorrected distance vision, reduction in residual refractive cylinder, and increased spectacle independence for distance vision. The device is intended to be placed in the capsular bag.

WARNINGS

Physicians considering lens implantation should weigh the potential risk/benefit ratio for any circumstances described in the TECNIS® Toric 1-Piece IOL Directions for Use that could increase complications or impact patient outcomes. These circumstances include recurrent severe anterior or posterior segment inflammation or uveitis; surgical difficulties at the time of cataract extraction, which may increase the potential for complications (e.g., persistent bleeding, significant iris damage, uncontrolled positive pressure or significant vitreous prolapse or loss); a compromised eye due to previous trauma or developmental defects in which appropriate support of the IOL is not possible; circumstances that would result in damage to the endothelium during implantation; suspected microbial infection; or patients in whom neither the posterior capsule nor the zonules are intact enough to provide support for the IOL.

See Full Indications and Important Safety Information for the TECNIS® Toric 1-Piece IOL.

FOR THE TECNIS SYMFONY® AND TECNIS SYMFONY® TORIC IOLs

Rx Only

INDICATIONS

The TECNIS Symfony® Extended Range of Vision IOL, model ZXR00, is indicated for primary implantation for the visual correction of aphakia, in adult patients with less than 1 diopter of pre-existing corneal astigmatism, in whom a cataractous lens has been removed. The lens mitigates the effects of presbyopia by providing an extended depth of focus. Compared to an aspheric monofocal IOL, the lens provides improved intermediate and near visual acuity, while maintaining comparable distance visual acuity. The model ZXR00 IOL is intended for capsular bag placement only. The TECNIS Symfony® Toric Extended Range of Vision IOLs, models ZXT150, ZXT225, ZXT300, and ZXT375, are indicated for primary implantation for the visual correction of aphakia and for reduction of residual refractive astigmatism in adult patients with greater than or equal to 1 diopter of preoperative corneal astigmatism, in whom a cataractous lens has been removed. The lens mitigates the effects of presbyopia by providing an extended depth of focus. Compared to an aspheric monofocal IOL, the lens provides improved intermediate and near visual acuity, while maintaining comparable distance visual acuity. The model series ZXT IOLs are intended for capsular bag placement only.

WARNINGS

Physicians considering lens implantation under any of the circumstances described in the Directions for Use should weigh the potential risk/benefit ratio as such patients may not be suitable candidates for an intraocular lens because the lens may exacerbate an existing condition, may interfere with diagnosis or treatment of a condition, or may pose an unreasonable risk to the patient’s eyesight.

ATTENTION

Reference the Directions for Use for a complete listing of Indications and Important Safety Information.

See Full Indications and Important Safety Information for the TECNIS Symfony® IOL.

See Full Indications and Important Safety Information for the TECNIS Symfony® Toric IOL.

FOR HEALON ENDOCOAT® OVD

Rx Only

INDICATIONS

HEALON EndoCoat® OVD is an ophthalmic viscoelastic containing 3% sodium hyaluronate indicated for use as a surgical aid in patients undergoing ophthalmic anterior segment procedures including: Cataract surgery with an intraocular lens, Cataract surgery without an intraocular lens, Secondary intraocular lens implantation. HEALON EndoCoat® OVD maintains a deep chamber during anterior segment surgery, aids in tissue manipulation during surgery, enhances visualization during the surgical procedure and protects the corneal endothelium and other ocular tissue. The viscoelasticity of the solution maintains the normal position of the vitreous face and prevents formation of a flat chamber during surgery. It may also be used to coat intraocular lenses and insertion instruments prior to intraocular lens implantation.

CONTRAINDICATIONS

At present, there are no contraindications to the use of Healon EndoCoat® OVD when used as recommended.

WARNINGS

The Healon EndoCoat® OVD Delivery system is not designed or intended to be attached to instruments other than the one provided with the product.

See Full Indications and Important Safety Information.

FOR HEALON5® OVD

Rx Only

INDICATIONS

HEALON5® OVD is intended for use in anterior segment ophthalmic surgical procedures of the human eye. The HEALON5® OVD is designed to create and maintain a deep anterior chamber which facilitates manipulation inside the eye with reduced trauma to the corneal endothelium and other ocular tissues. The HEALON5®OVD can also be used to efficiently separate and control ocular tissues. The HEALON5® OVD is not designed to have any pharmacological effect.

CONTRAINDICATIONS

There are no known contraindications to the use of the HEALON5® OVD when used as recommended

PRECAUTIONS 

Precautions normally considered during ophthalmic surgical procedures should be taken.

See Full Indications and Important Safety Information.

FOR HEALON® OVD

Rx Only

INDICATIONS

The HEALON® OVD is indicated for use as a surgical aid in cataract extraction (intra- and extracapsular), IOL implantation, corneal transplant, glaucoma filtration and retinal attachment surgery. In surgical procedures in the anterior segment of the eye, instillation of the HEALON® OVD serves to maintain a deep anterior chamber during surgery, allowing for efficient manipulation with less trauma to the corneal endothelium and other surrounding tissues. Furthermore, its viscoelasticity helps to push back the vitreous face and prevent formation of a postoperative flat chamber. In posterior segment surgery the HEALON® OVD serves as a surgical aid to gently separate, maneuver and hold tissues. The HEALON® OVD creates a clear field of vision thereby facilitating intra- and post-operative inspection of the retina and photocoagulation.

CONTRAINDICATIONS

At present there are no known contraindications to the use of the HEALON® OVD when used as recommended.

PRECAUTIONS

Those normally associated with the surgical procedure being performed. Overfilling the anterior or posterior segment of the eye with the HEALON® OVD may cause increased intraocular pressure, glaucoma, or other ocular damage.

See Full Indications and Important Safety Information.

FOR HEALON GV® OVD

Rx Only

INDICATIONS

The HEALON GV® OVD is indicated for use in anterior segment ophthalmic surgical procedures. The HEALON GV® OVD creates and maintains a deep anterior chamber, to facilitate manipulation inside the eye with reduced trauma to the corneal endothelium and other ocular tissues. The HEALON GV® OVD also can be used to efficiently maneuver, separate and control ocular tissues.

CONTRAINDICATIONS

There are no known contraindications to the use of the HEALON GV® OVD when used as recommended.

PRECAUTIONS

Precautions normally considered during ophthalmic surgical procedures should be taken.

See Full Indications and Important Safety Information.

BAERVELDT® GLAUCOMA IMPLANTS

Rx Only

INDICATIONS

For use in patients (with prior vitrectomy for Pars Plana) with medically uncontrollable glaucoma and poor surgical prognosis, such as, but not limited to: neovascular glaucoma, aphakic/pseudophakic glaucomas, patients who have failed conventional surgery, congenital glaucomas and secondary glaucomas due to uveitis, epithelial downgrowth, etc. 

WARNINGS

Do not use the device if sterile package integrity has been compromised. Do not resterilize the implant by any method. Do not reuse the implant. Do not store at temperatures above 45°C (113°F).

See Full Indications and Important Safety Information.

FOR THE CATALYS® PRECISION LASER SYSTEM
INDICATIONS

The OptiMedica® CATALYS® Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, phacofragmentation, and the creation of single plane and multi-plane arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure.

WARNINGS

Prior to INTEGRAL GUIDANCE System imaging and laser treatment, the suction ring must be completely filled with sterile buffered saline solution.

See Full Indications and Important Safety Information

FOR THE WHITESTAR SIGNATURE® PRO PHACOEMULSIFICATION SYSTEM
INDICATIONS

The WHITESTAR SIGNATURE® PRO System is a modular ophthalmic microsurgical system that facilitates anterior segment (cataract) surgery. The modular design allows the users to configure the system to meet their surgical requirements.

WARNINGS

All personnel who might operate this equipment must read and understand the instructions in this manual before they use the system.

See Full Indications and Important Safety Information.

FOR THE STAR S4 IR® EXCIMER LASER and AND iDESIGN® ADVANCED WAVESCAN STUDIO SYSTEM
CAUTION

U.S. Federal Law restricts this device to sale, distribution, and use by or on the order of a physician or other licensed eye care practitioner. 

ATTENTION

Reference the Operator’s Manual for a complete listing of Indications and Important Safety Information. 

INDICATIONS

The STAR S4 IR® Excimer Laser System and iDESIGN® Advanced WaveScan Studio (iDESIGN®) System is indicated for wavefront guided LASIK in patients with myopia as measured by iDESIGN® System up to -11.00 D SE, with up to -5.00 D cylinder; with agreement between manifest refraction (adjusted for optical infinity) and iDESIGN® System refraction of 1) SE: magnitude of the difference is ˂ 0.625 D, and 2) cylinder: magnitude of the difference is ≤ 0.5 D; with patients 18 years of age and older, and with refractive stability (a change of ≤ 1.0 D in sphere or cylinder for a minimum of 12 months prior to surgery). 

CONTRAINDICATIONS 

Laser refractive surgery is contraindicated in patients with: collagen vascular, autoimmune, or immunodeficiency diseases, pregnant or nursing women, keratoconus, abnormal corneal topography, epithelial basement membrane disease (EBMD) and degenerations of the structure of the cornea, symptoms of significant dry eyes, corneal thickness would cause anticipated treatment to violate the posterior 250 microns (μm) of corneal stroma, advanced glaucoma, and uncontrolled diabetes. If the patients have severely dry eyes, LASIK may increase the dryness; this may or may not go away. Severe eye dryness may delay healing of the flap or interfere with the surface of the eye after surgery; it may result in poor vision after LASIK. 

WARNINGS AND PRECAUTIONS

LASIK is not recommended in patients who: have a history of Herpes simplex or Herpes zoster keratitis, have severe allergies or tendency rub their eyes often, are taking the medication Isotretinoin (Accutane®), are taking antimetabolites for any medical conditions. The safety and effectiveness of this laser for LASIK correction have NOT been established in patients:  with progressive refractive errors; previous corneal or intraocular surgery; or trauma in the ablation zone, who are taking the medication Sumatriptan (Imitrex®), or Amiodarone hydrochloride (Cordarone®), with corneal neovascularization within 1.0 mm of the ablation zone, over the long term (more than 1 year after surgery), for patients who engage in activities that could endanger or damage the LASIK flap, for patients who have a family history of degenerative corneal disease, history of inflammation of the eye, for patients who have a history of crossed eyes (strabismus) or who have undergone strabismus surgery, prior LASIK or Refractive Surgery, with history of any eye diseases or abnormalities such as corneal scars or active disease, and whose BSCVA is worse than 20/20. To reduce the risk of corneal ectasia, the posterior 250 microns (μm) of corneal stroma should not be violated. The treatment of highly myopic eyes necessitates the removal of significant amounts of corneal tissue.  The iDESIGN® System calculates the estimated residual bed depth using the pachymetry and intended flap thickness entered by the user. Actual flap thicknesses may vary. If the estimated residual stromal bed is ≤ 320 microns, an in-the-bed pachymetric measurement should be performed.

ADVERSE EVENTS

Possible adverse events include loss of best spectacle corrected visual acuity (BSCVA), serious Transient Light Sensitivity Syndrome, serious primary open angle glaucoma, miscreated flap, melting of the flap, severe glare, and severe dry eyes. Complications can include corneal edema, epithelial ingrowth, diffuse lamellar keratitis, foreign body sensation, and pain.

See Full Indications and Important Safety Information for the iDESIGN® System.

 

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