Indications and Important Safety Information

RISKS
There are risks to routine cataract surgery. This is irrelevant to the lens you choose. The problems could be minor, temporary, or affect your vision permanently. Complications are rare. These may include are worsening of your vision, bleeding, or infection. Pre-existing diseases or conditions may place you at higher risk of experiencing complications (e.g., more difficult recovery) after routine cataract surgery. Examples of pre-existing diseases or conditions are diabetes, heart disease and previous trauma to your eye.

With some IOLs, you may experience some loss in the sharpness of your vision, even with glasses. With these IOLs, you may have more difficulty driving at night or in poor visibility conditions This can affect your ability to detect road hazards as quickly at night or in fog. You may also experience halos (rings around light), glare (reflected light, making it difficult to see) and starbursts (rays around light). A small number of patients may want to have their IOL removed. This can be due to lens-related optical/visual symptoms. You should discuss all risks and benefits with your eye doctor before surgery.

INDICATIONS AND IMPORTANT SAFETY INFORMATION for the TECNIS® Family of 1-Piece IOLs

Rx Only

INDICATIONS and IMPORTANT SAFETY INFORMATION for TECNIS Symfony™ and TECNIS Symfony™ TORIC EXTENDED RANGE OF VISION IOLs

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 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. These models of IOLs, ZXR00, ZXT150, ZXT225, ZXT300, and ZXT375, mitigate the effects of presbyopia by providing an extended depth of focus. Compared to an aspheric monofocal IOL, these models of IOLs provide improved intermediate and near visual acuity, while maintaining comparable distance visual acuity. These models of IOLs are intended for capsular bag placement only.

INDICATIONS and IMPORTANT SAFETY INFORMATION for TECNIS Symfony™ OPTIBLUE™ and TECNIS Symfony™ TORIC II OPTIBLUE™ EXTENDED RANGE OF VISION IOLs

The TECNIS Symfony™ OptiBlue™ Extended Range of Vision IOL, Model ZXR00V, 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 TECNIS Symfony™ Toric II OptiBlue™ Extended Range of Vision IOLs, Models ZXW150, ZXW225, ZXW300, ZXW375, 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. These models of IOLs, ZXR00V, ZXW150, ZXW225, ZXW300, ZXW375, mitigate the effects of presbyopia by providing an extended depth of focus. Compared to an aspheric monofocal IOL, these models of IOLs provide improved intermediate and near visual acuity, while maintaining comparable distance visual acuity. These models of IOLs are intended for capsular bag placement only.

INDICATIONS and IMPORTANT SAFETY INFORMATION for TECNIS SYNERGY™ and TECNIS SYNERGY™ TORIC II IOLs

The TECNIS Synergy™ IOL, Model ZFR00V, 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. Compared to an aspheric monofocal lens, the TECNIS Synergy™ IOL mitigates the effects of presbyopia by providing improved visual acuity at intermediate and near distances to reduce eyeglass wear, while maintaining comparable distance visual acuity. The lens is intended for capsular bag placement only. The TECNIS Synergy™ Toric II IOL, Models ZFW150, ZFW225, ZFW300, ZFW375, are indicated for primary implantation for the visual correction of aphakia and for the reduction of 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. Compared to an aspheric monofocal lens, the TECNIS Synergy™ Toric II IOLs mitigate the effects of presbyopia by providing improved visual acuity at intermediate and near distances to reduce eyeglass wear, while maintaining comparable distance visual acuity. The lens is intended for capsular bag placement only.

INDICATIONS FOR THE TECNIS® 1-PIECE MONOFOCAL IOL

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

INDICATIONS FOR THE TECNIS® MULTIFOCAL 1-PIECE AND TECNIS® MULTIFOCAL TORIC II IOLs

The TECNIS® Multifocal 1-Piece intraocular lenses are indicated for primary implantation for the visual correction of aphakia in adult patients with and without presbyopia in whom a cataractous lens has been removed by phacoemulsification and who desire near, intermediate, and distance vision with increased spectacle independence. The TECNIS® Multifocal Toric II lens models ZKU150, ZKU225, ZKU300, ZKU375 and ZLU150, ZLU225, ZLU300, ZLU375 are indicated for primary implantation for the visual correction of aphakia and for reduction of residual refractive astigmatism in adult patients with or without presbyopia, with greater than or equal to 1 diopter of preexisting corneal astigmatism, in whom a cataractous lens has been removed in order to provide near, intermediate and distance vision. The IOLs are intended for capsular bag placement only.

INDICATIONS FOR THE TECNIS® TORIC II 1-PIECE AND TECNIS® TORIC 1-PIECE IOLs

The TECNIS® Toric II 1-Piece and TECNIS® Toric 1-Piece IOL 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.

INDICATIONS FOR THE TECNIS EYHANCE™ AND TECNIS EYHANCE™ TORIC II IOLs

The TECNIS Eyhance™ IOL, Model ICB00 is indicated for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag. The TECNIS Eyhance™ Toric II IOLs, Models ICU150-ICU600, are 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 reduction in residual refractive cylinder. The lens is intended to be placed in the capsular bag.

WARNINGS: Physicians considering lens implantation under any of the conditions described in the Directions for Use should weigh the potential risk/benefit ratio prior to implanting a lens that could increase complications or impact patient outcomes. Do not place the lens in the ciliary sulcus. Inform patients about the possibility that a decrease in contrast sensitivity and an increase in visual disturbances may affect their ability to drive a car under certain environmental conditions, such as driving at night or in poor visibility conditions.

Rotation of the TECNIS® Toric, TECNIS® Toric II 1-Piece, TECNIS Eyhance™ Toric II and TECNIS Symfony™ Toric II OptiBlue™ IOLs away from its intended axis can reduce its astigmatic correction. Misalignment greater than 30° may increase postoperative refractive cylinder. If necessary, lens repositioning should occur as early as possible, prior to lens encapsulation. All preoperative surgical parameters are important when choosing a toric lens for implantation. Carefully remove all viscoelastic and do not over-inflate the capsular bag at the end of the case.

PRECAUTIONS: Prior to surgery, inform prospective patients of the possible risks and benefits associated with the use of this device and provide a copy of the patient information brochure to patient. The long-term effects of intraocular lens implantation have not been determined. Secondary glaucoma has been reported occasionally in patients with controlled glaucoma who received lens implants. Do not reuse, resterilize or autoclave. The safety and effectiveness of the TECNIS Eyhance™ IOLs have not been substantiated in clinical trials and the effects of the optical design on quality of vision, contrast sensitivity, and subjective visual disturbances (glare, halo, etc.) have not been evaluated clinically.

ADVERSE EVENTS: The most commonly reported adverse events that occurred during the clinical trials of the TECNIS® 1-Piece lenses were macular edema and secondary surgical re-intervention.

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

INDICATIONS AND IMPORTANT SAFETY INFORMATION for the CATALYS® Precision Laser System

CAUTION
Federal law (USA) restricts this device to sale by or on the order of a physician. The system should be used only by qualified physicians who have extensive knowledge of the use of this device and have been trained and certified.

ATTENTION
Reference the labeling for a complete listing of Important Indications and Safety Information.

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.

CONTRAINDICATIONS
The CATALYS System should not be used if you are not a candidate for cataract surgery, have certain pre-existing corneal problems or eye implants; or if you are younger than 22 years of age. Tell your doctor about any eye-related conditions, injuries, or surgeries.

PRECAUTIONS
Patients must be able to lie flat on their backs and motionless during the procedure. Patients must be able to tolerate local or topical anesthesia. Tell your doctor if you are taking any medications such as alpha blockers (like Flomax® to treat an enlarged prostate) as these medications may affect how the doctor does the cataract surgery.

ADVERSE EFFECTS
Complications associated with the CATALYS System include mild broken blood vessels or redness on the white part of your eye, which may last for a few weeks. Other potential risks associated with cataract surgery may occur. These risks may include but are not limited to corneal swelling and/or abrasion, lens capsular tear, infection, inflammation, eye discomfort, and reduced vision. Talk to your doctor regarding all the potential risks associated with these procedures.