AcrySof® IQ ReSTOR® IOL

Caution:
Restricted by law to sale by or on the order of a physician.
Description:
The AcrySof® IQ ReSTOR® Intraocular Lenses (IOLs) are artificial lenses implanted in the eye of adult patients following cataract surgery. These lenses are designed to allow for clear distance, intermediate, and near vision with the potential to be more independent of the need to use glasses for daily tasks.
Warnings/Precautions:
You may experience and need to contact your eye doctor immediately if you have any of the following symptoms while using the antibiotic eye drops prescribed by your doctor: itching, redness, watering of your eye, sensitivity to light. The safety and effectiveness of the AcrySof® IQ ReSTOR® IOL has not been established in patients with eye conditions, such as an increase in eye pressure (glaucoma) or complications of diabetes in the eye (diabetic retinopathy). As with any surgical procedure, there are risks involved. These risks may include but are not limited to infection, damage to the lining of the cornea, the retinal layer which lines the inside back wall of your eye may become separated from the tissue next to it (retinal detachment), inflammation or swelling inside or outside the eye, damage to the iris (the colored diaphragm around the pupil), an increase in eye pressure that cannot be controlled by medicine and secondary surgical procedure. With this IOL, there may be a loss of sharpness of your vision that may become worse in dim light or in foggy conditions. There is also a possibility that you may have some visual effects such as rings or circles around lights at night. You may also have trouble seeing street signs due to bright lights or glare from oncoming headlights.
Attention:
As with any surgical procedure, there are risks involved. Prior to surgery, ask your eye doctor to provide you with an AcrySof® IQ ReSTOR® IOL Patient Information Brochure, which will inform you of the risks and benefits associated with this IOL. Discuss any questions about possible risks and benefits with your eye doctor.

AcrySof® IQ IOL Important Product Information

Caution:
Federal (USA) law restricts this device to the sale by or on the order of a physician.
Indications:
The AcrySof® IQ Intraocular Lenses (IOLs) are artificial lenses implanted in the eye of adult patients following cataract surgery. These lenses are designed to allow for clear distance vision. However, you will likely still need glasses for reading and for distance vision particularly if you already have astigmatism.
Warnings/Precautions:
You may experience and need to contact your eye doctor immediately if you have any of the following symptoms while using the antibiotic eye drops prescribed by your doctor: itching, redness, watering of your eye, sensitivity to light. The safety and effectiveness of the AcrySof® IQ IOL has not been established in patients with certain eye conditions, such as an increase in eye pressure (glaucoma) or complications of diabetes in the eye (diabetic retinopathy). As with any surgical procedure, there are risks involved. These risks may include, but are not limited to, infection, damage to the ocular structures: lining (inner surface) of the cornea, damage to the iris (the colored diaphragm around the pupil), the retinal layer which lines the inside back wall of your eye may become separated from the tissue next to it (retinal detachment), inflammation or swelling inside or outside the eye, an increase in eye pressure that may not be controlled by medicine and secondary surgical procedure. There is a possibility that this IOL could be placed incorrectly or could move within the eye. This may result in less improvement or a reduction in vision, or it may cause visual symptoms.
Attention:
As with any surgical procedure, there are risks involved. Prior to surgery, discuss any questions you may have about possible risks and benefits with your eye doctor.

AcrySof® IQ Toric IOL Important Product Information

Caution:
Restricted by law to sale by or on the order of a physician.
Description:
The AcrySof® IQ Toric Intraocular Lenses (IOLs) are artificial lenses implanted in the eye of adult patients following cataract surgery. These lenses are designed to correct pre-existing corneal astigmatism, which is the inability of the eye to focus clearly at any distance because of difference curvatures on the cornea, and provide distance vision.
Warnings/Cautions:
You may experience and need to contact your eye doctor immediately if you have any of the following symptoms while using the antibiotic eye drops prescribed by your doctor: itching, redness, watering of your eye, sensitivity to light. The safety and effectiveness of the AcrySof® IQ Toric IOL has not been established in patients with eye conditions, such as an increase in eye pressure (glaucoma) or complications of diabetes in the eye (diabetic retinopathy). As with any surgical procedure, there are risks involved. These risks may include but are not limited to infection, damage to the lining of the cornea, the retinal layer which lines the inside back wall of your eye may become separated from the tissue next to it (retinal detachment), inflammation or swelling inside or outside the eye, damage to the iris (the colored diaphragm around the pupil), an increase in eye pressure that cannot be controlled by medicine and secondary surgical procedure. A toric IOL corrects astigmatism only when it is placed in the correct position in the eye. There is a possibility that the toric IOL could be placed incorrectly or could move within the eye. This may result in less improvement or a reduction in vision because your astigmatism has not been fully corrected, or it may cause visual symptoms.
Attention:
As with any surgical procedure, there are risks involved. Prior to surgery, ask your eye doctor to provide you with an AcrySof® IQ Toric IOL Patient Information Brochure, which will inform you of the risks and benefits associated with this IOL. Discuss any questions about possible risks and benefits with your eye doctor.

LenSx® Laser 

Caution: 
The LenSx® Laser is restricted by law to the sale and use by, or on the order of, a physician.
Description:
The LenSx® Laser is for use in patients undergoing cataract surgery. The laser is used as a tool to break up a cataract and to create incisions in the cornea. The LenSx® Laser uses an accessory called the LenSx® Laser Patient Interface to hold the eye steady during a procedure.
Warnings/Precautions: 
The LenSx® Laser Patient Interface holds an eye by applying light suction. Some bleeding and foreign body sensation may occur. As with any cataract surgery, there are risks involved. These risks may include but are not limited to infection, pain, corneal abrasion and capsular tear. 
Attention: 
Surgery with the LenSx® Laser is not for everyone. Conditions such as corneal opacity, glaucoma, a poorly dilating pupil and previous corneal surgery may preclude use of the LenSx® Laser. Your doctor can determine if the LenSx® Laser is right for you.

LASIK Important Safety Information

Indication:
LASIK (laser-assisted in situ keratomileusis) is a laser surgery procedure that permanently changes the shape of the cornea to reduce or eliminate nearsightedness, farsightedness, or mixed visual irregularities due to an abnormal curve in the cornea (astigmatism). Only an eye care professional trained in laser vision correction can determine if you are a candidate for this procedure. The iFS® laser is a surgical laser that can be used to create flaps for use in LASIK surgery.
Contraindications:
You should not have LASIK if you have collagen vascular (such as rheumatoid arthritis), autoimmune, or an immunodeficiency disease because they affect the body’s ability to heal. You should not have this procedure if you are pregnant or nursing, show signs of corneal thinning, or take medications with eye-related side effects, such as Isotretinoin (Accutane®) for acne treatment or Amiodarone hydrochloride (Cordarone®) for normalizing heart rhythm.
Warnings:
LASIK is not recommended if you have diabetes, a history of herpes simplex or herpes zoster keratitis, significant dry eye, or severe allergies.
Precautions:
Your doctor will examine your eyes to determine if you are a candidate for this procedure. Talk to your doctor about any eye-related conditions, injuries, or surgeries you have had, as well as any changes to your vision in the past year. These may result in poor vision after LASIK. Tell your doctor about any medications you are taking. After surgery, you may find it more difficult to see in conditions such as dim light, rain, snow, fog, or glare from bright lights at night. LASIK is for patients 21 years of age and over.
Side effects:
Possible side effects include dryness, which may be severe; loss of vision or the possible need for glasses or contact lenses after surgery; and visual disturbances such as halos (hazy rings around lights), glare, starbursts, double images, and other visual irregularities that may be debilitating. Possible complications resulting from LASIK flap creation include swelling, inflammation or pain in your eye, infection, or flap-related complications. Mild to severe light sensitivity occurred in 1% of patients between 2 and 6 weeks after surgery. Some patients (0.03%) noticed a temporary spoke-like band of light in their peripheral vision.
Please consult with your eye care professional and carefully review the Patient Information Booklet regarding the potential risks and benefits of this procedure. Results may vary for each individual patient.

The iLASIK® platform utilizes the STAR S4 IR® Excimer Laser System, WaveScan WaveFront® System, as well as the iFS® Advanced Femtosecond Laser during the LASIK procedure.

Caution:
U.S. Federal law restricts these devices to use by practitioners who have been trained in their calibration and operation, and who have experience in the surgical treatment and management of refractive errors.

 

STAR S4 IR® EXCIMER LASER iFS® FEMTOSECOND LASER

 
For U.S. Consumers Only

  • Problems swallowing, speaking, or breathing, due to weakening of associated muscles, can be severe and result in loss of life. You are at the highest risk if these problems are pre-existing before injection. Swallowing problems may last for several months 
  • Spread of toxin effects. The effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms including: loss of strength and all-over muscle weakness, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, loss of bladder control, trouble breathing, trouble swallowing

BOTOX® Cosmetic dosing units are not the same as, or comparable to, any other botulinum toxin product.

There has not been a confirmed serious case of spread of toxin effect when BOTOX® Cosmetic has been used at the recommended dose to treat frown lines, crow’s feet lines, or both at the same time. 

BOTOX® Cosmetic may cause loss of strength or general muscle weakness, vision problems, or dizziness within hours to weeks of taking BOTOX® Cosmetic. If this happens, do not drive a car, operate machinery, or do other dangerous activities.

Serious and/or immediate allergic reactions have been reported. They include: itching, rash, red itchy welts, wheezing, asthma symptoms, or dizziness or feeling faint. Get medical help right away if you are wheezing or have asthma symptoms, or if you become dizzy or faint.

Do not take BOTOX® Cosmetic if you: are allergic to any of the ingredients in BOTOX® Cosmetic (see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product such as Myobloc® (rimabotulinumtoxinB), Dysport® (abobotulinumtoxinA), or Xeomin® (incobotulinumtoxinA); have a skin infection at the planned injection site. 

Tell your doctor about all your muscle or nerve conditions, such as ALS or Lou Gehrig’s disease, myasthenia gravis, or Lambert-Eaton syndrome, as you may be at increased risk of serious side effects including difficulty swallowing and difficulty breathing from typical doses of BOTOX® Cosmetic. 

Tell your doctor about all your medical conditions, including: plans to have surgery; had surgery on your face; weakness of forehead muscles: trouble raising your eyebrows; drooping eyelids; any other abnormal facial change; are pregnant or plan to become pregnant (it is not known if BOTOX® Cosmetic can harm your unborn baby); are breast-feeding or plan to (it is not known if BOTOX® Cosmetic passes into breast milk). 

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal products. Using BOTOX® Cosmetic with certain other medicines may cause serious side effects. Do not start any new medicines until you have told your doctor that you have received BOTOX® Cosmetic in the past.

Tell your doctor if you have received any other botulinum toxin product in the last 4 months; have received injections of botulinum toxin such as Myobloc®, Dysport®, or Xeomin® in the past (tell your doctor exactly which product you received); have recently received an antibiotic by injection; take muscle relaxants; take an allergy or cold medicine; take a sleep medicine; take aspirin-like products or blood thinners. 

Other side effects of BOTOX® Cosmetic include: discomfort or pain at the injection site; headache; and eye problems: double vision, blurred vision, drooping eyelids, and swelling of your eyelids. 

For more information refer to the Medication Guide or talk with your doctor.

To report a side effect, please call Allergan at 1-800-433-8871.

Please see BOTOX® Cosmetic full Product Information including Boxed Warning and Medication Guide.