Eyeworld

APR 2017

EyeWorld is the official news magazine of the American Society of Cataract & Refractive Surgery.

Issue link: https://digital.eyeworld.org/i/804543

Contents of this Issue

Navigation

Page 81 of 238

AcrySof® IQ ReSTOR® Family of Multifocal IOLs 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 ReSTOR® Posterior Chamber Intraocular Multifocal IOLs include AcrySof® IQ ReSTOR® and AcrySof® ReSTOR® Toric are intended for primary implantation for the visual correction of aphakia secondary to removal of a cataractous lens in adult patients with and without presbyopia, who desire near, intermediate and distance vision with increased spectacle independence. In addition, the AcrySof IQ ReSTOR Toric IOL is intended to correct pre-existing astigmatism. The lenses are intended to be placed in the capsular bag. WARNINGS/PRECAUTIONS: Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to decide the risk/benefit ratio before implanting a lens in a patient with any of the conditions described in the Directions for Use labeling for each IOL. Physicians should target emmetropia, and ensure that IOL centration is achieved. Care should be taken to remove viscoelastic from the eye at the close of surgery. The ReSTOR Toric IOL should not be implanted if the posterior capsule is ruptured, if the zonules are damaged, or if a primary posterior capsulotomy is planned. Rotation can reduce astigmatic correction; if necessary lens repositioning should occur as early as possible prior to lens encapsulation. Some patients may experience visual disturbances and/or discomfort due to multifocality, especially under dim light conditions. A reduction in contrast sensitivity may occur in low light conditions. Visual symptoms may be significant enough that the patient will request explant of the multifocal IOL. Spectacle independence rates vary; some patients may need glasses when reading small print or looking at small objects. Posterior capsule opacification (PCO), when present, may develop earlier into clinically significant PCO with multifocal IOLs. Prior to surgery, physicians should provide prospective patients with a copy of the Patient Information Brochure available from Alcon informing them of possible risks and benefits associated with the AcrySof® IQ ReSTOR® IOLs. Do not resterilize; do not store over 45° C; use only sterile irrigating solutions such as BSS® or BSS PLUS® Sterile Intraocular Irrigating Solutions. ATTENTION: Reference the Directions for Use labeling for each IOL for a complete listing of indications, warnings and precautions. CyPass® Micro-Stent Important Product Information Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Indication: The CyPass® Micro-Stent is indicated for use in conjunction with cataract surgery for the reduction of intraocular pressure (IOP) in adult patients with mild to moderate primary open-angle glaucoma (POAG). Contraindications: Use of the CyPass® Micro-Stent is contraindicated in the following circumstances or conditions: (1) in eyes with angle closure glaucoma; and (2) in eyes with traumatic, malignant, uveitic or neovascular glaucoma or discernible congenital anomalies of the anterior chamber angle. MRI Information: The CyPass® Micro-Stent is magnetic resonance (MR) Safe: the implant is constructed of polyimide material, a non-conducting, non-metallic, non-magnetic polymer that poses no known hazards in all magnetic resonance imaging environments. Warnings: Gonioscopy should be performed prior to surgery to exclude peripheral anterior synechiae (PAS), rubeosis, and other angle abnormalities or conditions that would prohibit adequate visualization of the angle that could lead to improper placement of the stent and pose a hazard. Precautions: The surgeon should monitor the patient postoperatively for proper maintenance of intraocular pressure. The safety and effectiveness of the CyPass® Micro-Stent has not been established as an alternative to the primary treatment of glaucoma with medications, in patients 21 years or younger, in eyes with significant prior trauma, chronic inflammation, eyes with an abnormal anterior segment, eyes with chronic inflammation, eyes with glaucoma associated with vascular disorders, pseudophakic eyes with glaucoma, eyes with uveitic glaucoma, eyes with pseudoexfoliative or pigmentary glaucoma, eyes with other secondary open angle glaucomas, eyes that have undergone prior incisional glaucoma surgery or cilioablative procedures, eyes with laser trabeculoplasty performed ≤ 3 months prior to the surgical screening visit, eyes with unmedicated IOP less than 21 mmHg or greater than 33 mmHg, eyes with medicated IOP greater than 25 mmHg, in the setting of complicated cataract surgery with iatrogenic injury to the anterior or posterior segment, and when implantation is without concomitant cataract surgery with IOL implantation for visually significant cataract. The safety and effectiveness of use of more than a single CyPass® Micro-Stent has not been established. Adverse Events: In a randomized, multicenter clinical trial comparing cataract surgery with CyPass® Micro- Stent to cataract surgery alone, the most common post-operative adverse events included: BCVA loss of 10 or more letters at 3 months after surgery (8.8% for CyPass® vs. 15.3% for cataract surgery only); anterior chamber cell and flare requiring steroid treatment 30 or more days after surgery (8.6% vs. 3.8%); worsening of visual field mean deviation by 2.5 or more decibels (6.7% vs. 9.9%); IOP increase of 10 or more mmHg 30 or more days after surgery (4.3% vs. 2.3%); and corneal edema 30 or more days after surgery, or severe in nature (3.5% vs. 1.5%). Attention: Please refer to the Product Instructions for a complete list of contraindications, warnings, precautions and adverse events. i LO U N G E Saturday, May 6, 2017 9:30 am - 10:30 am "Don't overlook me!" Innovations for the Low Cylinder Cataract Patient Kevin Everett, MD, James Davison, MD, William Wiley, MD 10:30 am - 11:30 am The ACTIVEFOCUS™ toric: A New Option for Presbyopia and Astigmatism Correction with One Lens Donald Serafano, MD, Quentin Allen, MD, Jack Chapman, MD 11:30 am - 12:30 pm CYPASS Micro Stent®: First Impressions and Surgical Case Reviews Brian Flowers, MD, Sameh Mosaed, MD, Nathan Radcliffe, MD 12:30 pm - 1:00 pm Women Innovating Now Beth Zemkoski and Everlie Hamilton 1:00 pm - 2:00 pm Femto+Phaco in your OR: How to Increase Efficiency Kendall Donaldson, MD, Neel Desai, MD, Carlos Martinez, MD 2:00 pm - 3:00 pm New Learnings with CONTOURA® Vision Doyle Stulting, MD, Sissimos Lemonis, Alcon, Stephen Wexler, MD 3:00 pm - 3:30 pm CENTURION® Vision System: Increase your Control Edward Holland, MD Sunday, May 7, 2017 9:30 am - 10:30 am CYPASS Micro Stent®: First Impressions and Surgical Case Reviews Mark Gallardo, MD, Gregory Katz, MD, Robert Noecker, MD 10:30 am - 11:30 am New Learnings with CONTOURA® Vision Ronald Krueger, MD, Sissimos Lemonis, Alcon, Mark Lobanoff, MD 11:30 am - 12:30 pm Addressing your Patients' Needs with the ACRYSOF® IQ RESTOR® +2.5 with ACTIVEFOCUS™ Optical Design Randy Epstein, MD, Paul Ernest, MD, Jeff Horn, MD 12:30 pm - 1:00 pm LENSX® Laser System: Are you Ready for Femto? Satish Modi, MD 1:00 pm - 2:00 pm CENTURION® Vision System with INTREPID® Transformer I/A Handpiece: Phaco-Dynamics and Advancements Stephen Lane, MD, John Berdahl, MD, Damien Goldberg, MD 2:00 pm - 3:00 pm 2017 Alcon Surgeon Panel: Innovation in Action Q&A Session Nicholas Batra, MD, John Davidson, MD, Terry Kim, MD, Andrew Maxwell, MD, Dan Tran, MD 3:00 pm - 3:30 pm CYPASS Micro Stent®: First Impressions and Surgical Case Reviews Quang Nguyen, MD Times and presenters are subject to change. Visit the Alcon booth at the 2017 ASCRS meeting and join us for these engaging programs. All presenters are paid consultants or employees of Alcon.

Articles in this issue

Archives of this issue

view archives of Eyeworld - APR 2017