Surgical
SofPort® Advanced Optics Aspheric Lens System - Brief Statement
Indications
The Bausch & Lomb SofPort® Advanced Optics Aspheric Lenses
are intended to be used for primary implantation for the visual correction of
aphakia in patients 60 years of age or older where a cataractous lens has been
removed by extracapsular cataract extraction methods. They are intended for
placement in the ciliary sulcus or capsular bag. NOTE: Implantation of
intraocular lenses should not be performed in patients under 18 years of
age.
Warnings
As with any surgical procedure, there is risk involved. Potential
complications accompanying cataract or implant surgery may include but are not
limited to the following: lens dislocation, manifestations of inflammation,
corneal endothelial damage, infection (endophthalmitis), retinal detachment,
vitritis, cystoid macular edema, corneal edema, pupillary or cyclitic membrane,
iris prolapse, hypopyon, and transient or persistent glaucoma.
The safety and effectiveness of this lens, if placed in the anterior chamber,
has not been established. Implantation of posterior chamber lenses in the
anterior chamber has been shown in some cases to be unsafe. Such implantation
should take place only under an investigational protocol approved by the
FDA.
Pupillary block may be prevented by one or more iridectomies performed at the
time of implantation.
The long-term effects of intraocular lens implantation have not been
determined. Therefore, physicians should continue to monitor implant patients
postoperatively on a regular basis.
Undesirable optical effects such as glare, halos, etc. have been reported by
some patients after intraocular lens implantation. These phenomena are not
completely understood but are thought to be related to positioning holes and
edge effects.
The effectiveness of these lenses in reducing the incidence of retinal
disorders has not been established.
The safety of intraocular lens implantation has not been substantiated in
patients with pre-existing ocular conditions (e.g., chronic drug miosis,
glaucoma, amblyopia, diabetic retinopathy, previous corneal transplant, history
of retinal detachment, iritis, etc.). Physicians considering lens implants in
such patients should explore the use of alternative methods of aphakic
correction and consider lens implantation only if alternatives are deemed
unsatisfactory to meet the needs of the patient.
Patients with preoperative problems such as corneal endothelial disease,
abnormal cornea, macular degeneration, glaucoma, and chronic drug miosis may
not achieve the visual acuity of patients without such problems. The physicians
must determine the benefits to be derived from lens implantation when such
conditions exist.
Patients who experience surgical complications associated with the cataract
extraction procedure (posterior capsule rupture, detached Descemet's membrane,
anterior chamber bleeding, iris damage, or vitreous bulge or loss) may
experience poorer visual acuity. Medical judgment must be exercised to
determine if a lens should be implanted when surgical problems occur.
Patients who experience postoperative complications, particularly macular
edema, may have a slightly higher risk of experiencing poorer visual outcome
than patients without sight-threatening complications.
Precautions
Do not resterilize these lenses by any method. Do not store lenses at temperatures over 45°C. Use only sterile intraocular irrigating solutions, e.g., balanced salt or normal saline solution, to rinse and/or soak lenses. Patients with any of the following conditions may not be suitable candidates for an intraocular lens because the lens may exacerbate an existing condition, or may interfere with diagnosis or treatment of a condition, or may pose an unreasonable risk to the patient's eyesight:
- Congenital bilateral cataracts
- Recurrent anterior or posterior segment inflammation of unknown etiolog
- 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 cataract extraction which might increase the potential for complications; e.g., persistent bleeding, significant iris damage, uncontrollable positive pressure or significant vitreous prolapse or loss
- Patients with only one eye with potentially good vision
- Medically uncontrollable glaucoma
- Corneal endothelial dystrophy
- Proliferative diabetic retinopathy
It is recommended that each patient receive information regarding intraocular lenses in a manner that is suitable to the patient. This information should be provided prior to the decision to implant an intraocular lens. Postoperative information should also be provided by the physician.
Adverse Events
The following adverse reactions have been reported: Hyphema, macular edema,
secondary glaucoma, cyclitic membrane, vitritis, retinal detachment, lens
dislocation, hypopyon, intraocular infection, acute corneal decompensation, and
secondary surgical intervention.
