Eyeworld Daily News

5/17 US-CYP-17-E-0810 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 indicat- ed for use in conjunction with cataract surgery for the reduction of intraocular pressure (IOP) in adult patients with mild to moderate prima- ry 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-con- ducting, 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 ab- normalities 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 mainte- nance 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 pseudo- exfoliative 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, multi- center 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 ste- roid 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 Instruc- tions for a complete list of contraindications, warnings, precautions and adverse events. AcrySof IQ ReSTOR Family of 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 Lens (IOL) is intended for primary implantation for the visual correction of aphakia secondary to removal of a catarac- tous lens in adult patients with and without presbyopia, who desire near, intermediate and distance vision with increased spectacle inde- pendence. The lens is 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/ben- efit ratio before implanting a lens in a patient with any of the conditions described in the Directions for Use labeling. 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. Some patients may experience visual disturbances and/or discomfort due to multifocality, especially under dim light con- ditions. As with other multifocal IOLs, visual symptoms may be significant enough that the patient will request explant of the multifocal IOL. Spectacle independence rates vary with all multifocal IOLs; as such, some patients may need glasses when reading small print or look- ing at small objects. Clinical studies with the AcrySof ReSTOR lens indicated that posterior capsule opacification (PCO), when present, de- veloped earlier into clinically significant PCO. Prior to surgery, physicians should provide prospective patients with a copy of the Patient Information Brochure available from Alcon for this product informing them of possible risks and benefits associated with the AcrySof IQ ReSTOR IOLs. Studies have shown that color vision discrimination is not adversely affected in individuals with the AcrySof Natural IOL and normal color vision. The effect on vision of the AcrySof Natural IOL in subjects with hereditary color vision defects and acquired color vision defects secondary to ocular disease (e.g., glaucoma, diabetic retinopathy, chronic uve- itis, and other retinal or optic nerve diseases) has not been studied. 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 a complete listing of indications, warnings and precautions.

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