Indications and Important Safety Information

Important Safety Information

Cataract Surgery

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 TECNIS FAMILY OF 1-PIECE IOLs 

CAUTION: Federal law restricts this device to sale and use by or on the order of a physician.  

INDICATIONS 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 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 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 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 are intended for capsular bag placement only. 

INDICATIONS 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 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 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 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 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. 

CONTRAINDICATION

None.

IMPORTANT SAFETY INFORMATION

Routine cataract surgery risks, irrelevant to lens selection, could be minor, temporary, or affect patients’ vision permanently. Rare complications are worsening of vision, bleeding, or infection. Discuss all risks and benefits with your eye doctor before surgery. If the patient’s eye is unhealthy (including glaucoma), vision may not be good even after cataract removal; patients may not get full benefit of the IOL. Before surgery, the eye doctor will check for any eye diseases. Patients’ vision with the IOL may not be good enough to perform detailed ‘up-close’ work without glasses, and rarely, may make some types of retinal treatment (e.g., retinal tear repair) more difficult. You should avoid any activity that could harm your eye while you are recovering from surgery. Your doctor will tell you what activities to avoid while you are recovering from surgery. TECNIS Multifocal, TECNIS Symfony IOLs, and TECNIS Symfony OptiBlue Extended Range of Vision IOLs: Risks related to use of this lens include a slight loss in vision sharpness with decreased use of glasses. Even with glasses, loss of sharpness may worsen under poor visibility conditions such as dim light or fog. Patients may also notice halos, starbursts, glare, and other visual symptoms with extended range of vision and multifocal IOLs. This may lead to driving difficulties, and not detecting road hazards as quickly at night or in fog. This may impact patients when there are bright lights at night.  Therefore, you may need to take extra care when driving, especially in poor light conditions. A small number of patients may want their TECNIS Symfony, TECNIS Symfony OptiBlue or TECNIS Multifocal IOL removed because of lens-related optical/visual symptoms. TECNIS Toric IOLs: A Toric IOL corrects astigmatism when it is placed correctly in the eye. There is a chance that the Toric IOL could be placed incorrectly or could move within the eye. Your doctor may need to move the lens to the right position following surgery. If the Toric lens is not placed correctly, you may have visual distortions. A second surgery may be needed to properly position the lens. TECNIS EYHANCE IOLs: The effects of the TECNIS EYHANCE and TECNIS EYHANCE Toric II IOL optical design on quality of vision, contrast sensitivity, and subjective visual disturbances (glare, halo, etc.) have not been evaluated clinically.  

SIDE EFFECTS

Side effects of cataract surgery with the TECNIS Family of 1-Piece IOLs may include swelling/thickening of an area of the retina, and/or the need for a second surgery to reposition the lens, repair the retina, or remove the new lens. 

ATTENTION

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

INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR TECNIS SYNERGY AND TECNIS SYNERGY TORIC II IOL WITH TECNIS SIMPLICITY DELIVERY SYSTEM, MODELS DFR00V AND DFW 

CAUTION

Federal law restricts this device to sale, distribution and use by or on the order of a physician.

INDICATIONS FOR USE

The TECNIS Simplicity Delivery System is used to fold and assist in inserting the TECNIS Synergy IOL, which 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 Simplicity Delivery System is used to fold and assist in inserting the TECNIS Synergy Toric II IOLs, which are indicated for primary implantation for the visual correction of aphakia and for 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 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.

CONTRAINDICATION

None.

RISKS

Routine cataract surgery risk, irrespective of lens selection, could be minor, temporary, or affect patients’ vision permanently. Rare complications are worsening of vision, bleeding, or infection. Risks related to use of this lens include halo or glare in nighttime or poor visibility conditions. These may be perceived as an annoyance or hindrance, which, on rare occasions, may be significant enough for the patient to request removal of the IOL. Patients should discuss all risks and benefits with their eye doctor before surgery.

PRECAUTIONS

Recent contact lens usage may affect the patient’s refraction; therefore, in contact lens wearers, surgeons should establish corneal stability without contact lenses prior to determining IOL power. Prior to surgery, the surgeon must 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 the patient. Patients with a predicted postoperative astigmatism greater than 1.0 D may not be suitable candidates for implantation with the TECNIS Synergy and TECNIS Synergy Toric IOLs, as they may not obtain the benefits of reduced spectacle wear or improved intermediate and near vision seen in patients with lower postoperative astigmatism. The safety and effectiveness of the TECNIS Synergy IOL have not been substantiated in patients under the age of 22 or those with preexisting ocular conditions and intraoperative complications.

WARNINGS

Physicians considering lens implantation should weigh the potential risk/benefit ratio. Well-informed patients with well-defined visual needs and preferences should be selected for lens implantation. Patients should be informed of the possibility of visual effects (such as halo or glare around lights), which may be expected in nighttime or poor visibility conditions.

INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR TECNIS SYNERGY AND TECNIS SYNERGY TORIC II IOL WITH TECNIS SIMPLICITY DELIVERY SYSTEM, MODELS DFR00V AND DFW 

CAUTION

Federal law restricts this device to sale, distribution and use by or on the order of a physician.

INDICATIONS FOR USE

The TECNIS Simplicity Delivery System is used to fold and assist in inserting the TECNIS Synergy IOL, which 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 Simplicity Delivery System is used to fold and assist in inserting the TECNIS Synergy Toric II IOLs, which are indicated for primary implantation for the visual correction of aphakia and for 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 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.

CONTRAINDICATION

None.

RISKS

Routine cataract surgery risk, irrespective of lens selection, could be minor, temporary, or affect patients’ vision permanently. Rare complications are worsening of vision, bleeding, or infection. Risks related to use of this lens include halo or glare in nighttime or poor visibility conditions. These may be perceived as an annoyance or hindrance, which, on rare occasions, may be significant enough for the patient to request removal of the IOL. Patients should discuss all risks and benefits with their eye doctor before surgery.

PRECAUTIONS

Recent contact lens usage may affect the patient’s refraction; therefore, in contact lens wearers, surgeons should establish corneal stability without contact lenses prior to determining IOL power. Prior to surgery, the surgeon must 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 the patient. Patients with a predicted postoperative astigmatism greater than 1.0 D may not be suitable candidates for implantation with the TECNIS Synergy and TECNIS Synergy Toric IOLs, as they may not obtain the benefits of reduced spectacle wear or improved intermediate and near vision seen in patients with lower postoperative astigmatism. The safety and effectiveness of the TECNIS Synergy IOL have not been substantiated in patients under the age of 22 or those with preexisting ocular conditions and intraoperative complications.

WARNINGS

Physicians considering lens implantation should weigh the potential risk/benefit ratio. Well-informed patients with well-defined visual needs and preferences should be selected for lens implantation. Patients should be informed of the possibility of visual effects (such as halo or glare around lights), which may be expected in nighttime or poor visibility conditions.

INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR TECNIS SYMFONY OPTIBLUE AND TECNIS SYMFONY TORIC II OPTIBLUE EXTENDED RANGE OF VISION IOLs

CAUTION

Federal law restricts this device to sale and use by or on the order of a physician.

INDICATIONS FOR USE

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.

CONTRAINDICATION

None.

RISKS

Routine cataract surgery risks, irrespective of lens selection, could be minor, temporary, or affect patients’ vision permanently. Rare complications include worsening of vision, bleeding, or infection. Risks related to use of this lens include a slight loss in vision sharpness. Even with glasses, loss of sharpness may worsen under poor visibility conditions such as dim light or fog. This may lead to driving difficulties and not detecting road hazards as quickly at night or in fog. Patients may also notice halos, starbursts, glare, and other visual symptoms. This may impact patients when there are bright lights at night. Patients should discuss all risks and benefits with their eye doctor before surgery.

WARNINGS

A small number of patients may want their TECNIS Symfony OptiBlue IOL removed because of lens-related optical/visual symptoms. Patients with pre-existing diseases or conditions (i.e., diabetes and heart disease) may have higher risk of experiencing complications (e.g., more difficult recovery) after routine cataract surgery. Patients should not receive this lens if they have had previous trauma to their eye. The lens has not been evaluated for use in children.

PRECAUTIONS

If a patient’s eye is unhealthy, vision may not improve following cataract surgery in cases where other ocular conditions are present (e.g. glaucoma); patients may not get the full benefit of the TECNIS Symfony OptiBlue IOL. Before surgery, the eye doctor will check for any eye diseases. After surgery, patients should take all prescribed medicines and apply eye drops as instructed to avoid inflammation and infection. During recovery, patients should avoid bending down and playing sports, which can harm the eye. The eye doctor will tell patients what activities to avoid. Patients’ vision with the IOL may be limited when performing detailed ‘up-close’ work without glasses, and rarely, may make some types of retinal treatment (e.g., retinal tear repair) more difficult.

INDICATIONS and IMPORTANT SAFETY INFORMATION for TECNIS EYHANCETM and TECNIS EYHANCETM Toric II IOLs with TECNIS SIMPLICITY DELIVERY SYSTEM

RX Only

INDICATIONS FOR USE

The TECNIS Simplicity Delivery System is used to fold and assist in inserting the TECNIS EYHANCETM IOL 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 Simplicity Delivery System is used to fold and assist in inserting the TECNIS EYHANCETM Toric II IOLs 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.

CONTRAINDICATIONS

There are no known conditions under which the TECNIS EYHANCE and TECNIS EYHANCE Toric II IOLs should not be used.

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 worsening of your vision, bleeding, or infection. Similar to other monofocal IOLs, patients implanted with the TECNIS EYHANCE or TECNIS EYHANCE Toric II IOLs may require glasses for some tasks. Discuss all risks and benefits with your eye doctor prior to surgery.

WARNINGS

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 include, but are not limited to: ocular inflammation, surgical difficulties at the time of cataract extraction, suspected eye infection, congenital bilateral cataract, history or predisposition to retinal detachment, patients with only one good eye with potentially good vision, medically uncontrollable glaucoma, diabetes, heart disease, and previous trauma to your eye. The TECNIS EYHANCE Toric II IOL corrects astigmatism when it is placed correctly in the eye. There is a chance that the TECNIS EYHANCE Toric II IOL could be placed incorrectly or could move within the eye, resulting in visual distortions. A second surgery may be needed to properly position the lens. These lenses have not been evaluated for use in children.

PRECAUTIONS

The effects of the TECNIS EYHANCE and TECNIS EYHANCE Toric II IOL optical design on quality of vision, contrast sensitivity, and subjective visual disturbances (glare, halo, etc.) have not been evaluated clinically. If your eye is not healthy (including glaucoma), your vision may not be good even after your cataract is removed. In this case, you may not get the full benefit of the TECNIS EYHANCE and TECNIS EYHANCE Toric II IOLs. Before surgery, your eye doctor will check if you have any eye diseases that may influence your IOL selection. In rare instances, the TECNIS EYHANCE and TECNIS EYHANCE Toric II IOLs may make some types of retinal treatment (e.g., retinal tear repair) more difficult. Take all prescribed medicines and apply eye drops as instructed to avoid inflammation and infection. Your eye doctor may tell you if you should avoid certain activities after surgery.

SIDE EFFECTS

Side effects of cataract surgery with the TECNIS EYHANCE and TECNIS EYHANCE Toric II IOLs may include swelling/thickening of an area of the retina, and/or the need for a second surgery to reposition the lens, repair the retina, or remove the new lens.

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. 

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