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THE MICRO-IMPLANTATION CATARACT SUITE

The Micro-implantation Cataract Suite from Abbott Medical Optics is composed of five separate components, each designed to create synergies that maximize the benefits of Micro-implantation.

TECNIS® 1-Piece IOLs
Advancing micro-implantation through optics, materials and design.

UNFOLDER Platinum 1 Series Implantation System
The next-generation, precision-controlled micro-implantation system is designed specifically for the TECNIS® 1-Piece family of IOLs.

WHITESTAR SIGNATURE System
The perfect balance of control, confidence and performance in a micro-implantation procedure.

HEALON® OVD Family
The ultimate in protection, control, clarity and ease-of-use during each phase of micro-implantation, regardless of technique.

Accessories
Tips, sleeves, knives, and other tools and accessories, each specifically designed to work within the micro-implantation procedure.

Indications and Important Safety Information

TECNIS® Toric 1-Piece IOL

Caution

Do not use the lens if the package has been damaged. The sterility of the lens may have been compromised.

Device Description

The TECNIS® Toric 1-piece lens is an ultraviolet-light absorbing posterior chamber intraocular lens (IOL) which compensates for corneal spherical aberrations and corneal astigmatism. It is designed to be positioned in the lens capsule where the lens should replace the optical function of the natural crystalline lens. The TECNIS® Toric 1-piece IOL incorporates a proprietary wavefront-designed toric aspheric optic with a squared posterior optic edge designed to provide a 360 degree barrier. The edge of the optic has a frosted design to reduce potential edge glare effects. The anteriorly located cylinder axis marks denote the meridian with the lowest power.

Indications For Use

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

Precautions

  1. Do not resterilize the lens. Most sterilizers are not equipped to sterilize the soft acrylic material without producing undesirable side effects.
  2. Do not soak or rinse the intraocular lens with any solution other than sterile balanced salt solution or sterile normal saline.
  3. Do not store the lens in direct sunlight or at a temperature greater than 113°F (45°C). Do not autoclave the intraocular lens.
  4. Please refer to the specific instructions for use provided with the insertion instrument or system for the amount of time the IOL can remain folded before the IOL must be discarded.
  5. When the insertion system is used improperly, the haptics of the TECNIS® Toric 1-piece lens may become broken. Please refer to the specific instructions for use provided with the insertion instrument or system.

Warnings

Physicians considering lens implantation under any of the following circumstances should weigh the potential risk/benefit ratio:

  1. Patients with recurrent severe anterior or posterior segment inflammation or uveitis.
  2. Patients in whom the intraocular lens may affect the ability to observe, diagnose or treat posterior segment diseases.
  3. 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).
  4. A compromised eye due to previous trauma or developmental defects in which appropriate support of the IOL is not possible.
  5. Circumstances that would result in damage to the endothelium during implantation.
  6. Suspected microbial infection.
  7. Patients in whom neither the posterior capsule nor the zonules are intact enough to provide support for the IOL.
  8. Children under the age of 2 years are not suitable candidates for intraocular lenses.
  9. The TECNIS® Toric 1-piece IOL should be placed entirely in the capsular bag and should not be placed in the ciliary sulcus.
  10. Rotation of TECNIS® Toric 1-piece IOLs away from their intended axis can reduce their 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.
  11. Carefully remove all viscoelastic from the capsular bag. Residual viscoelastic may allow the lens to rotate, causing misalignment of the TECNIS® Toric 1-piece IOL with the intended axis of placement.

Adverse Events

Potential adverse events during or following surgery of the TECNIS® Toric 1-piece lens may include but are not limited to:

  • Endophthalmitis
  • Hypopyon
  • Pupillary block
  • Retinal detachment
  • Acute corneal decompensation
  • Secondary surgical intervention (including implant repositioning, removal, AC tap or other surgical procedure).

Attention

Reference the Directions for Use for a complete listing of indications, warnings, and precautions.

 

TECNIS® Monofocal IOLs

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

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 extracapsular cataract extraction. These devices are intended to be placed in the capsular bag.

Warnings
Physicians considering lens implantation under any of the conditions described in the Directions for Use labeling should weigh the potential risk/benefit ratio prior to implanting a lens.

Precautions
Do not resterilize or autoclave. Use only sterile irrigating solutions such as balanced salt solution or sterile normal saline. Do not store in direct sunlight or over 45°C.

Adverse Events
The most frequently reported adverse event that occurred during the clinical trial of the 1-Piece lens was macular edema, which occurred at a rate of 3.3%. Other reported reactions occurring in less than 1% of patients were secondary surgical intervention (pars plana vitrectomy with membrane peel) and lens exchange (due to torn lens haptic).

Attention
Reference the Directions for Use for a complete listing of indications, warnings and precautions.

TECNIS® Multifocal IOL

Caution
Federal law restricts this device to sale by or on the order of a physician.
 
Indications
TECNIS®
multifocal 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 intraocular lenses are intended to be placed in the capsular bag.

Warnings
Physicians considering lens implantation under any of the conditions described in the Directions for Use labeling should weigh the potential risk/benefit ratio prior to implanting a lens. Some visual effects associated with multifocal IOLs may be expected because of the superposition of focused and unfocused images. These may include a perception of halos/glare around lights under nighttime conditions. It is expected that, in a small percentage of patients, the observation of such phenomena will be annoying and may be perceived as a hindrance, particularly in low illumination conditions. On rare occasions these visual effects may be significant enough that the patient will request removal of the multifocal IOL. The splitting of the light into more than one focus may affect image quality and lead to some reduction of contrast sensitivity. Under low-contrast conditions, contrast sensitivity is reduced with a multifocal lens compared to a monofocal lens. Therefore, patients with multifocal lenses should exercise caution when driving at night or in poor visibility conditions. Patients with a predicted postoperative astigmatism >1.0 D may not be suitable candidates for multifocal IOL implantation since they may not fully benefit from a multifocal IOL in terms of potential spectacle independence. Care should be taken to achieve IOL centration as lens decentration may result in patients experiencing visual disturbances, particularly in patients with large pupils under mesopic conditions.

Precautions
The central one-millimeter area of the lens creates a far image focus, therefore patients with abnormally small pupils (~1 mm) should achieve, at a minimum, the prescribed distance vision under photopic conditions; however, because this multifocal design has not been tested in patients with abnormally small pupils, it is unclear whether such patients will
derive any near vision benefit. Autorefractors may not provide optimal postoperative refraction of multifocal patients; manual refraction is strongly recommended. In contact lens wearers, surgeons should establish corneal stability without contact lenses prior to determining IOL power. Care should be taken when performing wavefront measurements as two different wavefronts are produced (one will be in focus (either far or near) and the other wavefront will be out of focus); therefore incorrect interpretation of the wavefront measurements is possible. The long-term effects of intraocular lens implantation have not been determined; therefore
implant patients should be monitored postoperatively on a regular basis. Secondary glaucoma has been reported occasionally in patients with controlled glaucoma who received lens implants. The intraocular pressure of implant patients with glaucoma should be carefully monitored postoperatively. Do not resterilize or autoclave. Use only sterile irrigating solutions such as balanced salt solution or sterile normal saline. Do not store in direct sunlight or over 45° C. Emmetropia should be targeted as this lens is designed for optimum visual performance when emmetropia is achieved. Care should be taken to achieve centration.

Adverse Events
The most frequently reported adverse event that occurred during the clinical trial of the TECNIS® Multifocal lens was surgical reintervention, which occurred at a rate of 3.7% (lens-related 0.6%; non–lens-related 3.2%). Secondary surgical intervention included biometry error, retinal repair, iris prolapse/wound repair, trabeculectomy, lens repositioning, and patient dissatisfaction. The second most reported adverse event was macular edema, which occurred at a rate of 2.6%. Other reported reactions were hypopyon and endophthalmitis occurring in 0.3% of patients, respectively.

Attention
Reference the Directions for Use for a complete listing of indications, warnings, and precautions.

 

UNFOLDER Platinum 1 Series Implantation System

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

Indications
The UNFOLDER Platinum 1 Series Implantation System is used to fold and assist in inserting TECNIS® 1-Piece intraocular lenses (IOL), ONLY into the capsular bag.

Warnings
The UNFOLDER Platinum 1 Series Implantation System should only be used with TECNIS® 1-Piece IOLs. Do not use if the cartridge tip is cracked or split prior to implantation. Never release the plunger until the optic body has been completely released from the cartridge tube. The lens and cartridge should be discarded if the lens has been folded within the cartridge for more than 5 minutes. If the IOL is not properly placed in the cartridge, the IOL may be damaged and/or implanted upside down. The Model 1MTEC30 cartridge is intended for single use only. AMO single-use medical devices are labeled with instructions for use and handling to minimize exposure to conditions which may compromise the product, patient or the user. Do not attempt to modify or alter this device or any of the components, as this can significantly affect the function and/or structural integrity of the design. Use of methyl cellulose viscoelastics is not recommended as they have not been validated with this implantation system. Do not implant lens if rod tip becomes jammed in the cartridge.

Precautions
The use of viscoelastics is required when loading the IOL into the cartridge. For optimal performance use the AMO HEALON® family of viscoelastics. Do not use balanced salt solution. The combination of low operating room temperatures and high IOL diopter powers may require a slower delivery. Do not use if any component of this implantation system has been dropped or inadvertently struck while outside of the shipping case. Do not store the cartridges at temperatures under 5°C or over 30°C.

Contraindications
Do not use the handpiece if the rod tip appears nicked or damaged in any way.

 

WHITESTAR SIGNATURE System

The WHITESTAR SIGNATURE System is a modular ophthalmic microsurgical system that facilitates anterior segment (cataract) surgery. Risk and complications may include broken ocular capsule or corneal burn. Please reference the WHITESTAR SIGNATURE System Operator’s Manual for more information on intended use, warnings and precautions.

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

Warnings and Cautions
All personnel who might operate this equipment must read and understand the instructions in the operator’s manual before the system is used. Failure to do so might result in the improper operation of the system. This device is only to be used by a trained licensed physician. The fluid level in the balanced salt solution bottle must be monitored by the surgical nursing staff. The result of a low bottle or an empty bottle affects the fluid balance and the intra-ocular pressure (IOP) while aspirating. The low or empty bottle can result in the inadvertent chamber shallowing or collapse, the Aspiration of tissue, or an ultrasonic wound heating commonly called wound burn (extreme case). The surgical staff must monitor the fluid level at all times. DO NOT use the System in the presence of flammable anesthetics, or other flammable gases, near flammable fluids or objects, or in the presence of oxidizing agents, as a fire could result. The unit might interfere with any cardiac pacemaker fitted to the patient; therefore qualified advice must be obtained prior to such use. The output power selected must be as low as possible for the intended purpose. Do not use the system near conductive materials such as metal bed parts, inner spring mattresses, or similar items. Replace electrode cables on evidence of deterioration. Not recommended for use in condensing environments. If exposed to a condensing environment, allow the system to equilibrate to typical operating room conditions prior to use. This high frequency surgical equipment is specified for use without a neutral electrode. Failure of the high frequency surgical equipment could result in an unintended increase of output power. Sterility assurance is the responsibility of the user. All non-sterile accessories must be sterilized prior to use. Prior to using any invasive portions of the handpiece assembly, examine under the microscope for any obvious damage, oxidation, or the presence of foreign material. If any questionable characteristics are noted, use a backup handpiece for surgery. Use of contaminated or damaged system accessories can cause patient injury. Use of non-AMO approved products with the WHITESTAR SIGNATURE System, can affect overall system performance and is not recommended. AMO cannot be responsible for system surgical performance if these products are utilized in surgery.

Contraindications and Adverse Events
Risks and complications may include broken ocular capsule or corneal burn. Please reference the WHITESTAR SIGNATURE Operators Manual for more information on intended use, warnings and precautions.

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

 

HEALON® Ophthalmic Viscoelastic Device (OVD)

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

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.

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. Postoperative intraocular pressure may also be elevated as a result of pre-existing glaucoma, compromised outflow and by operative procedures and sequelae thereto, including enzymatic zonulysis, absence of an iridectomy, trauma to filtration structures, and by blood and lenticular remnants in the anterior chamber. Since the exact role of these factors is difficult to predict in any individual case, the following precautions are recommended:

  • Don’t overfill the eye chambers with the HEALON® OVD (except in glaucoma surgery).
  • In posterior segment procedures in aphakic diabetic patients special care should be exercised to avoid using large amounts of the HEALON® OVD.
  • Remove some of the HEALON® OVD by irrigation and/or aspiration at the close of surgery (except in glaucoma surgery).
  • Carefully monitor the intraocular pressure, especially during the immediate postoperative period. If significant rises are observed, treat with appropriate therapy.

Care should be taken to avoid trapping air bubbles behind the HEALON® OVD.  Because the HEALON® OVD is a highly purified fraction extracted from avian tissues and is known to contain minute amounts of protein, the physician should be aware of potential risks of the type that can occur with the injection of any biological material.  Because of reports of an occasional release of minute rubber particles, presumably formed when the diaphragm is punctured, the physician should be aware of this potential problem.  Express a small amount of the HEALON® OVD from the syringe prior to use, and carefully examine the remainder as it is injected.  Reprocessed cannulas should not be used.  Sporadic reports have been received indicating that the HEALON® OVD may become cloudy or form a slight precipitate following instillation into the eye. The clinical significance of these reports, if any, is not known since the majority received to date do not indicate any harmful effects on ocular tissues.  The physician should be aware of this phenomenon and, should it be observed, remove the cloudy or precipitated material by irrigation and/or aspiration.  In vitro laboratory studies suggest that this phenomenon may be related to interactions with certain concomitantly administered ophthalmic medications.  Use only if solution is clear.

Adverse Events
The HEALON® OVD is extremely well tolerated after injection into human eyes. A transient rise of intraocular pressure postoperatively has been reported in some cases.  In posterior segment surgery intraocular pressure rises have been reported in some patients, especially in aphakic diabetics, after injection of large amounts of the HEALON® OVD.  Rarely, postoperative inflammatory reactions (iritis, hypopyon) as well as incidents of corneal edema and corneal decompensation have been reported. Their relationship to the HEALON® OVD has not been established.

Attention
Reference the Directions for Use for a complete listing of indications, warnings, and precautions.

 

HEALON5 Ophthalmic Viscoelastic Device (OVD)

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

Indications
The 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.

Precautions
Precautions normally considered during ophthalmic surgical procedures should be taken. Special care should be taken to ensure complete removal of the HEALON5 OVD from the entire eye including behind the lens and the chamber angles. Complete removal of the HEALON5 OVD is important to avoid intraocular pressure peaks postoperatively. Due to the greater viscosity and higher concentration of sodium hyaluronate in the HEALON5 OVD, the rise in the postoperative intraocular pressure may be higher with the HEALON5 OVD than if the same volume of other sodium hyaluronate viscoelastic products, with lower zero shear viscosity, is left in the anterior segment of the eye. Before initiating phacoemulsification, use irrigation/aspiration to create a fluid-filled space above the lens. This reduces the risk of initial visco-occlusion of the phaco tip or the irrigation line which could cause phaco tip heating. Pre-existing glaucoma, other causes of compromised outflow, higher preoperative intraocular pressure and complications in surgical procedures may also lead to increased intraocular pressure; consequently, extra care should be taken in patients with these conditions. Prophylactic pressure-lowering treatment should always be considered and especially in cases where the HEALON5 OVD has to be left in the eye for clinical reasons.

Adverse Events
Increased intraocular pressure has been reported after use of sodium hyaluronate solutions. Increased intraocular pressure is likely to occur if the HEALON5 OVD is not removed as completely as possible. Clinical judgment concerning the use of this product should be considered in cases where thorough removal may not be possible. The precautions noted above should be taken to manage any increased postoperative intraocular pressure and to reduce the likelihood of occurrence of related postoperative complications such as optic neuropathy, pupillary atonia and dilation, and iris atrophy. Rarely, postoperative inflammatory reactions (iritis, hypopyon, endophthalmitis) following the use of sodium hyaluronate, as well as incidents of corneal edema and corneal decompensation, have been reported. Their relationship to sodium hyaluronate has not been established.

Attention
Reference the Directions for Use for a complete listing of indications, warnings, and precautions.

 

HEALON GV Ophthalmic Viscoelastic Device (OVD)

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

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.

Precautions: 
Precautions normally considered during ophthalmic surgical procedures should be taken. Postoperative intraocular pressure may be increased if the HEALON GV OVD is left in the eye. Due to the greater viscosity of the HEALON GV OVD, this increase in postoperative IOP may be higher than that caused by leaving the same amount of other sodium hyaluronate viscoelastic products, with lower zero shear viscosity, in the anterior chamber. Since rises in postoperative intraocular pressure, including cases of significant elevation and subsequent complications, have been reported, the following precautions are strongly recommended:

  • Special care should be taken to ensure as complete removal as possible by continuing to irrigate/aspirate after you see displacement of the initial bolus of viscoelastic from the eye, continued irrigation/aspiration should facilitate removal of viscoelastic which may remain in the anterior segment.
  • Pre-existing glaucoma, other causes of compromised outflow, higher preoperative intraocular pressure and complications in surgical procedures also may lead to increased intraocular pressure, consequently, extra care should be taken in patients with these conditions.
  • Carefully monitor intraocular pressure, particularly during the early postoperative period.
  • Treat with appropriate intraocular pressure lowering therapy, if required.

The HEALON GV OVD is a highly purified fraction extracted from avian tissues which may contain minute amounts of protein. The potential risks associated with the injection of biological material should be considered. Express a small amount of the HEALON GV OVD from the syringe prior to use and carefully examine it during use to avoid injecting minute rubber particles which may be released when the syringe diaphragm is punctured. Sodium hyaluronate solution may appear cloudy or form precipitates when it is injected. Based on in vitro laboratory studies, this phenomenon may be related to interactions with concomitantly used ophthalmic medications or detergents which remain in reused cannulas. Reprocessed cannulas should not be used.

Adverse Events
Increased intraocular pressure has been reported after use of the HEALON GV OVD. Increased intraocular pressure is likely to occur if the HEALON GV OVD is not removed as completely as possible. Clinical judgement concerning the use of this product should be considered in cases where thorough removal may not be possible. The precautions noted above should be taken to manage any increased postoperative intraocular pressure and to reduce the likelihood of occurrence of related postoperative complications such as  optic neuropathy, pupillary atonia and dilation, and iris atrophy. Rarely, postoperative inflammatory reactions (iritis, hypopyon, endophthalmitis) following the use of sodium hyaluronate, as well as incidents of corneal edema and corneal decompensation, have been reported. Their relationship to sodium hyaluronate has not been established.

Attention
Reference the Directions for Use for a complete listing of indications, warnings, and precautions.


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