UltraSert® Pre-Loaded Delivery System Surgical Pearls

Aug 31, 2018



 

© 2018 Novartis 8/18 US-ULS-18-E-1580e

IMPORTANT PRODUCT INFORMATION UltraSert® Pre-loaded IOL Delivery System with the AcrySof® IQ aspheric IOLCAUTION: Federal (USA) law restricts this device to the sale by or on the order of a physician. INDICATIONS: The AcrySof® IQ aspheric intraocular lens (“AcrySof IQ”) is intended for the replacement of the human lens to achieve visual correction of aphakia in adult patients following cataract surgery. This lens is intended for placement in the capsular bag. WARNING/PRECAUTION: Use the UltraSert® Pre-loaded Delivery System (“UltraSert”) at temperatures between 18o C (64o F) and 23oC (73o F). Use only Alcon viscoelastics qualified for this device. Do not use the UltraSert if the nozzle appears damaged or deformed. Follow the Directions for Use for correct order and sequence of steps to avoid damage to the IOL or the UltraSert. Careful preoperative evaluation and sound clinical judgement 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. Caution should be used prior to lens encapsulation to avoid lens decentrations or dislocations. Studies have shown that color vision discrimination is not adversely affected in the 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 uveitis, and other retinal or optic nerve diseases) has not been studied. Do not resterilize: do not store over 45o C. ATTENTION: Reference the Directions for Use for Model AU00T0 for a complete listing of indications, warnings and precautions.

Important Product Information AcrySof® Family of Single-Piece IOLs (AcrySof® UV, AcrySof ®IQ, AcrySof® IQ Toric, AcrySof®IQ ReSTOR®, and AcrySof® IQ ReSTOR® Toric IOLs)CAUTION: Federal law restricts these devices to sale by or on the order of a physician. INDICATION: The family of AcrySof® single-piece intraocular lenses (IOLs) includes AcrySof® UV-absorbing IOLs (“AcrySof® UV”), AcrySof ®IQ, AcrySof ®IQ Toric® and AcrySof IQ ReSTOR® and AcrySof® IQ ReSTOR® Toric IOLs. Each of these IOLs is indicated for visual correction of aphakia in adult patients following cataract surgery. In addition, the AcrySof Toric IOLs are indicated to correct pre-existing corneal astigmatism at the time of cataract surgery. The AcrySof IQ ReSTOR IOLs are for cataract patients with or without presbyopia, who desire increased spectacle independence with a multifocal vision. All of these IOLs are intended for placement in the capsular bag. WARNINGS/PRECAUTIONS:General cautions for all AcrySof® and AcrySof® UV IOLs: Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to decide the risk/benefit ratio before implanting any IOL in a patient with any of the conditions described in the Directions for Use that accompany each IOL. Caution should be used prior to lens encapsulation to avoid lens decentration or dislocation. Viscoelastic should be removed from the eye at the close of surgery. Additional Cautions associated with AcrySof® IQ ReSTOR® IOLs: 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 with all multifocal IOLs; as such, some patients may need glasses when reading small print or looking at small objects. Clinical studies indicate that posterior capsule opacification (PCO), when present, may develop earlier into clinically significant PCO with multifocal IOLs. Additional Cautions associated with AcrySof® IQ Toric, AcrySof® UV Toric and ReSTOR® Toric IOLs: Optical theory suggests that, high astigmatic patients (i.e. > 2.5 D) may experience spatial distortions. Possible toric IOL related factors may include residual cylindrical error or axis misalignments. Toric IOLs 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. Prior to surgery, physicians should provide prospective patients with a copy of the appropriate Patient Information Brochure available from Alcon informing them of possible risks and benefits associated with the AcrySof® IQ Toric, AcrySof® IQ ReSTOR® and AcrySof® IQ ReSTOR® Toric IOLs. Do not resterilize. Do not store at temperatures over 45° C. Use only sterile irrigating solutions to rinse or soak IOLs. ATTENTION: Refer to the Directions for Use labeling for the specific IOL for a complete list of indications, warnings and precautions.

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