Trulign Toric IOL Indications and Safety Information

INDICATIONS FOR USE

The Trulign Toric Posterior Chamber Intraocular Lens (IOL) is intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia and postoperative refractive astigmatism secondary to removal of a cataractous lens in adult patients with or without presbyopia who desire reduction of residual refractive cylinder with increased spectacle independence and improved uncorrected near, intermediate and distance vision.

WARNINGS

  • Rotation of toric lenses away from their intended axis can reduce their effectiveness. Misalignment can increase postoperative refractive cylinder. Repositioning of this lens to the intended axis should only be performed when a significant reduction in the effectiveness of the Trulign Toric IOL is noticed. This lens should only be repositioned when the refractive needs of the patient outweigh the potential risks inherent in any surgical reintervention into the eye.
  • YAG-laser posterior capsulotomies should be delayed until at least 12 weeks after the implant surgery. The posterior capsulotomy opening should be limited to no more than 4 mm. Consistent with other IOLs, there is an increased risk of lens dislocation and/or secondary surgical re-intervention with early or large YAG capsulotomies.
  • The Trulign Toric IOL should not be implanted if the capsular bag is not intact or if there is any zonular rupture.
  • The rate of cystoid macular edema may increase with sulcus-bag placement of the haptics.
  • Do not implant this lens in the anterior chamber or ciliary sulcus.
  • Unlike most other IOLs, the Trulign Toric optic has hinges connecting it to the haptic. There are adverse events in which the optic becomes stuck in an anterior, posterior, and/or tilted (asymmetric) or decentered position and the hinges become fixed in a displaced configuration. These events are referred to as cases of “lens vault” or “vaulting” and typically cause blurry vision and unexpected myopia, hyperopia, and/or astigmatism, and possibly higher order aberrations. When vaulting occurs, secondary surgery is often required to restore the correct optic position or sometimes to remove the lens. The following are important considerations:
    • Vaulting is sometimes associated with excessive postoperative capsular fibrosis. Consider surgical techniques and medication to minimize this inflammation and implementing an appropriate follow-up schedule to detect early signs of excessive capsular fibrosis.
    • Ensure proper IOL placement through rotation and visual inspection.
    • A wound leak could cause anterior vaulting of the optic. Therefore a scleral tunnel or long multiplane limbal/corneal incision is recommended with long narrow paracenteses. Ensure all incisions are watertight and do not leak.
    • During surgery, the optic should be vaulted backward to a position corresponding to the normal location of the posterior capsule. Attempts to position the lens further posteriorly by hyper-inflating the globe with BSS could lead to posterior vaulting and hyperopic outcomes, and should be avoided.
    • Asymmetric and excessive fibrosis of the capsule may be associated with asymmetric vaulting. Contributing factors may include decentration or tear of the anterior or posterior capsule, or ruptured zonules. If any of these are present before lens implantation, do not implant the Trulign Toric.

PRECAUTIONS

  • Some patients may still require glasses to perform certain tasks.
  • There is no clinical data to support placing this lens in the ciliary sulcus.
  • The safety and effectiveness of this lens have not been evaluated in patients under 50 years of age.
  • Before implantation of the TRULIGN Toric IOL, surgeons should verify that the cornea is appropriately marked for the steep axis.
  • The effect of vitrectomy on near performance of the TRULIGN Toric IOL is unknown.
  • The safety and effectiveness of the device has not been established in patients with the following ocular conditions: chronic drug miosis, amblyopia, diabetic retinopathy, previous corneal transplant, history of retinal detachment, congenital bilateral cataracts, recurrent anterior or posterior segment inflammation of unknown etiology or any disease producing an inflammatory reaction in the eye, patients in whom the intraocular lens may interfere with the ability to observe, diagnose, or treat posterior segment diseases, surgical difficulties at the time of intraocular lens implantation which might increase the potential for complications, corneal endothelial dystrophy, pseudo exfoliation syndrome, or suspected microbial infection. Surgeons considering lens implantation in such patients should explore the potential risk/benefit ratio before implanting a lens in a patient with one or more of these conditions.
  • Mechanical hinge testing has been evaluated in a laboratory setting. Hinge movements of 1,000,000 cycles at 10 cycles per second have been documented with no degradation of hinge integrity or stability. However, long-term stability in the human eye has not been established. Therefore, surgeons should continue to monitor implant patients postoperatively on a regular basis.
  • The potential for the lens to rotate causing misalignments that will reduce the effectiveness of the Trulign Toric IOL may be greater in some eyes.
  • Lens rotation less than 5° may not warrant reorientation.
  • Do not resterilize this intraocular lens by any method.
  • Do not store lenses at temperatures over 45°C (113°F).
  • The safety and effectiveness of the TRULIGN Toric intraocular lenses have not been substantiated in patients with the certain preexisting ocular conditions and intraoperative complications (see below). Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to decide the benefit/risk ratio before implanting a lens in a patient with one or more of these conditions.
    • Before Surgery: choroidal hemorrhage, chronic severe uveitis, concomitant severe eye disease, extremely shallow anterior chamber, medically uncontrolled glaucoma, microphthalmos, non-age-related cataract, severe optic nerve atrophy, or irregular corneal astigmatism
    • During Surgery: excessive vitreous loss, capsulotomy by any technique other than a circular tear, presence of radial tears known or suspected at the time of surgery, situations in which the integrity of the circular tear cannot be confirmed by direct visualization, cataract extraction by techniques other than phacoemulsification or liquefaction, situations where the need for a large capsulotomy can be anticipated
  • The effectiveness of the TRULIGN Toric IOL in reducing the visual effect of preoperative corneal astigmatism of less than 1.33 diopters has not been established.
  • If a surgeon chooses to implant an eye with greater than 3.00 diopters of preoperative corneal astigmatism or greater than 2.50 diopters of predicted postoperative corneal astigmatism, it is likely that only a limited correction will be achieved and device effectiveness is expected to be less than that seen in the clinical trial described in this labeling.
  • In the clinical trial conducted for FDA device approval, all corneal incisions were placed at the preoperative keratometric steep axis. If the surgeon chooses to place the incision at a different location (or in some other way differing from the practice in the clinical trial) results may be different from those portrayed in the clinical study results section of this labeling. It is unknown to what extent the angle between the incision and the meridian of steepest corneal curvature affects the accuracy of the prediction of the TRULIGN Toric IOL Calculator.
  • If the surgeon uses methods other than the TRULIGN Toric IOL Calculator, to determine appropriate toric cylinder power and appropriate axis placement, the results achieved may not be similar to those described in the clinical study results section of the labeling.
  • The intermediate and near performance in lenses below 16 diopter spherical equivalent power has not been clinically studied.
  • In cases where patients are monocular or have much poorer acuity in the fellow eye, they should exercise extreme caution if this happens in potentially hazardous situations (such as driving). If the patient experiences blurred vision, they should contact their physician promptly, as this may indicate a problem with lens positioning.

ADVERSE EVENTS

The incidence of adverse events experienced during the clinical trial was comparable to or lower than the incidence reported in the historic control (“FDA grid”) population. As with any surgical procedure, risk is involved. Potential adverse events accompanying cataract or implant surgery may include, but are not limited to, the following: lens subluxation, corneal endothelial damage, non-pigment precipitates, cystoid macular edema, infection (endophthalmitis), retinal detachment, vitreous loss, pupillary block, corneal edema, hypopyon, secondary glaucoma, iris prolapse, vitreous-wick syndrome, uveitis, secondary surgical intervention and pupillary membrane. Secondary surgical interventions include, but are not limited to: lens repositioning, lens replacement, vitreous aspirations or iridectomy for pupillary block, wound leak repair and retinal detachment repair.

Vaulting

Vaulting is a post-operative adverse event where the TRULIGN Toric lens optic hinges move into and remain in a displaced configuration. Vaulting events occurred at a rate of 0.3% (1 events / 324 subjects) in the clinical study conducted for the original Crystalens AO IOL (Model AT-45), and at a rate of 0.9% (2 events / 227 subjects; both arms combined) in the clinical study conducted for the TRULIGN Toric IOL (a modification having the same hinged haptic design; ModelAT50T). The optic may be displaced anteriorly, posteriorly, or tilted / decentered. Vaulting takes three forms: anterior vault (both hinges are displaced anteriorly), posterior vault (both hinges are displaced posteriorly), and asymmetric vault (z-syndrome) (one hinge is displaced anteriorly and one hinge is displaced posteriorly).

Vaulting Symptoms:

  • Vaulting typically presents with blurry vision, which may either gradual or acute in onset.
  • Blurry vision after cataract surgery may be due to various other conditions and patients are advised to contact their surgeons if they notice a change in vision.

Vaulting Diagnosis:

Diagnosis of vault is based on the IOL configuration, which can be visualized with a slit lamp.

  • Anterior vault – both hinges and optic are displaced anteriorly, away from the posterior capsule.
  • Posterior vault – both hinges and optic are displaced posteriorly, causing excessive posterior bowing of the posterior capsule.
  • Asymmetric vault – one hinge is displaced anteriorly and one is displaced posteriorly, causing the optic to tilt.

Additional clinical findings that support the diagnosis of vault include:

  • Excessive capsular contraction – fibrotic bands, striae, and opacification visualized at slit lamp
  • Changes in refractive error – measured through manual or automatic refraction
    • Anterior vault – optic is displaced anteriorly, resulting in myopic shift
    • Posterior vault – optic is displaced posteriorly, resulting in hyperopic shift
    • Asymmetric vault – optic is tilted, resulting in astigmatism along the axis of the tilt

Slit lamp photographic images of as asymmetric vault are included in the Directions for Use (DFU).

Definitive causes of vaulting have not been established. Factors that have been suggested as potentially contributing to vaulting include the following:

  • Asymmetric anterior capsulotomy – The Trulign Toric IOL is symmetric and the lens optic is intended to rest in the center of the capsular bag post-implantation. Asymmetric capsulotomy may result in asymmetric amount of capsular contact with the IOL which, during post-operative capsular contraction, may lead to asymmetric forces acting upon the IOL hinges.
  • Incomplete removal of lens material – Extensive medical literature has established that residual lens material can incite an exuberant post-operative inflammatory reaction. Post-operative inflammation can precipitate excessive capsular fibrosis, which may lead to excessive capsular contractile forces acting upon the IOL hinges.
  • Capsular defect – A defect in the capsule will result in asymmetric capsular support for the IOL and possibly decentration or tilt of the IOL. During post-operative capsular fibrosis, these factors may lead to asymmetric contractile forces acting upon the IOL hinges and worsening of decentration / tilt.
  • Zonular defect – Zonules provide support and balance for the capsular bag / IOL. Loss of zonular support can lead to decentration or tilt of the capsular bag and asymmetric forces acting upon the IOL hinges.
  • Incorrect IOL placement – Examples of incorrect placed include: IOL haptic footplates not even placed around the capsular equator, one or more haptic footplates placed in the sulcus instead of the capsular bag, IOL placed in an upside-down configuration. Each of these scenarios may cause the IOL to move in as asymmetric manner or the hinges to remain “stuck” in a flexed configuration.
  • Wound leak – Wound leak allows fluid to egress from the anterior chamber to the external corneal surface, resulting in low and fluctuating levels of anterior chamber stability. Low anterior chamber pressure relative to posterior vitreous pressure may push the IOL optic anteriorly, resulting in anterior vault.
  • Excessive postoperative inflammation and excessive capsular fibrosis – Persistent post-operative inflammation is associated with excessive capsular fibrosis. Capsular fibrosis may cause contractile forces to act upon the IOL hinges.

If any of the vaulting risk factors are present before lens implantation, do not implant the Trulign Toric IOL.

Potential Sequelae of Vaulting:

  • Vaulting commonly induces refractive error (e.g. myopia, hyperopia or astigmatism) which may be reversible if the Trulign Toric can be restored to its normal position.
  • Vaulting commonly presents as blurry vision, which can be either gradual or acute in onset. Vaulting may be reversible by restoring the IOL to its normal position, which may require surgery.
  • The treatment for vaulting may require secondary surgical intervention.

Physicians should consider the characteristics of each individual vaulting case prior to determining the appropriate treatment. Data on long-term follow-up after treatment of vaulting is not available.

ATTENTION: Refer to the Directions for Use labeling for a complete listing of indications, warnings and precautions, clinical trial information, etc.

CAUTION: Federal (USA) law restricts this device to the sale by or on the order of a physician.