*mymedicalexpo

Catalogs
Alcon
MODEL SN6AD1

MODEL SN6AD1

Product catalog summary

Product Description: The AcrySof® IQ ReSTOR® Intraocular Lenses (IOLs) are foldable multifocal lenses designed for implantation in the eye's posterior chamber. They filter ultraviolet and blue light, mimicking the natural crystalline lens. Made from high refractive index acrylic material, they feature an apodized diffractive structure to enhance depth of focus.

Physical Characteristics: The lenses are available in two models, SN6AD1 and SN6AD3, with near vision add powers of +3.0 and +4.0 diopters, respectively. Both models have a 6.0 mm optic diameter and a 13.0 mm overall length, designed with STABLEFORCE® haptics for stability.

Mode of Action: These IOLs replace the natural lens to correct aphakia, providing increased depth of focus and compensating for corneal spherical aberration. They offer options for different reading distances based on patient preference.

Indications: Intended for adult patients with cataract-induced aphakia, with or without presbyopia, seeking reduced dependence on spectacles for near, intermediate, and distance vision.

Warnings: Patients may experience visual effects like halos or reduced contrast sensitivity, especially in low light. Optimal outcomes require targeting emmetropia and careful lens centration.

Precautions: Patients should be informed of potential risks. The lenses may not be suitable for those with certain pre-existing ocular conditions or intraoperative complications. High surgical skill is required for implantation.

Calculation of Lens Power: Accurate biometry and personalized lens constants are crucial for successful outcomes. Surgeons should use their experience and preferred methods for power calculations.

Directions for Use: Detailed instructions are provided for handling and implanting the lenses, emphasizing sterility and proper surgical techniques.

Patient Registration and Reporting: Post-implantation, patients must be registered with Alcon for long-term follow-up. Adverse events should be reported to Alcon Laboratories.

Clinical Studies: Various studies have been conducted on AcrySof® IOLs, though specific effects of the aspheric surface on visual outcomes have not been assessed.

Clinical Study Overview: Clinical studies in the US and Europe evaluated the safety and effectiveness of the AcrySof® ReSTOR® Apodized Diffractive Optic IOL. The studies included 566 first-eye implanted ReSTOR® IOL patients and 194 AcrySof® MA60BM Monofocal IOL Control patients. A Best Case cohort was analyzed, excluding patients with significant preoperative ocular pathology or postoperative macular degeneration.

Demographics: The study population was 65.3% female and 34.7% male, with a racial composition of 93.9% Caucasian, 2.6% Black, 0.9% Asian, and 2.5% other. The mean age was 68.8 years.

Visual Acuity Results: ReSTOR® IOL subjects showed significant improvement in uncorrected photopic and distance-corrected photopic near vision compared to monofocal controls. Binocular implantation resulted in visual acuities similar to monofocal controls, while monocular implantation showed a decrease in distance visual acuity. Older subjects (≥ 80 years) with ReSTOR® lenses had poorer uncorrected distance visual acuity compared to controls.

Binocular Visual Acuity: At six months postoperative, binocular visual acuity results showed that a high percentage of ReSTOR® IOL patients achieved 20/40 or better vision, both for distance and near photopic conditions.

Monocular Visual Acuity: Monocular visual acuity results indicated that ReSTOR® IOL patients had better near vision compared to monofocal controls, with significant differences observed in uncorrected and distance-corrected conditions.

Intermediate Vision: A supplemental study evaluated intermediate vision performance, showing that ReSTOR® IOLs had comparable results to monofocal controls at certain distances, although some differences were noted at 70 cm.

Contrast Sensitivity: Contrast sensitivity and low contrast acuity were generally equivalent between ReSTOR® IOL and monofocal control patients, with some reduction in contrast sensitivity under mesopic conditions with glare.

Driving Sub-study: Night driving performance was assessed using a Night Driving Simulator. ReSTOR® IOL patients demonstrated similar abilities to detect and identify road signs and hazards at night compared to monofocal controls under normal visibility conditions.

Introduction: This document presents a comparative analysis of the performance of monofocal and ReSTOR® intraocular lenses (IOLs) under various visibility conditions. It includes data on sign identification, hazard detection, retinal detail, quality of life, adverse events, and visual disturbances.

Sign Identification and Hazard Detection: Rural Conditions: The ReSTOR® lens showed a mean difference of less than 15% in sign identification distances compared to monofocal lenses under normal, fog, and glare conditions. Hazard detection differences were also under 20%. City Conditions: In city driving conditions, the ReSTOR® lens subjects experienced a 28% reduction in text sign identification under glare conditions, with smaller differences for warning signs. Hazard detection differences were less than 15%.

Retinal Detail and Quality of Life: No difficulties in retinal treatment were reported, although one investigator noted a loss of retinal detail in some cases. ReSTOR® IOLs showed statistically better spectacle independence rates compared to controls.

Adverse Events: The ReSTOR® IOLs had a few adverse events exceeding FDA grid rates, including retinal detachment/repair and surgical reinterventions. However, no persistent adverse events were observed.

Visual Disturbances: ReSTOR® IOL patients reported higher rates of visual disturbances such as glare, halos, and night vision problems compared to monofocal controls.

AcrySof® IQ ReSTOR® IOLs Clinical Study: A study on AcrySof® IQ ReSTOR® IOL Models SN6AD3 and SN6AD1 showed comparable performance in near and distance visual acuity, with SN6AD1 providing better intermediate visual acuity. The study highlighted differences in best focus distances for near vision, offering options based on patient lifestyle.

Visual Acuity and Defocus: Both models achieved similar binocular visual acuity results, with SN6AD1 showing a 20% increase in the distance of best near visual acuity compared to SN6AD3. The defocus curve indicated similar peaks for both models, with SN6AD1 having a slightly reduced amplitude of functional vision.

Conclusion: The document provides a comprehensive analysis of the performance and outcomes of ReSTOR® IOLs compared to monofocal lenses, highlighting differences in visual performance, quality of life, and adverse events.

Specifications and Performance: The document compares two models of AcrySof® IQ ReSTOR® IOLs, SN6AD1 (+3.0 D) and SN6AD3 (+4.0 D), focusing on visual acuity and intermediate vision. SN6AD1 provides better uncorrected and distance-corrected intermediate visual acuity, with significant improvements over SN6AD3 at distances of 50 cm, 60 cm, and 70 cm.

Visual Acuity: SN6AD1 offers twice the near to intermediate range of vision at 20/25 or better compared to SN6AD3. It maintains a visual acuity of better than 20/32 from approximately 12 inches to infinity.

Contrast Sensitivity: Both models show clinical equivalence in contrast sensitivity under various lighting conditions, with differences in mean contrast sensitivity being less than 0.15 log units.

Patient-Reported Outcomes: High rates of spectacle independence were reported, with over 78% of patients in both groups not requiring glasses. Patient satisfaction was high, with most patients willing to have the lenses implanted again.

Visual Disturbances: There were no significant increases in severe visual disturbances with SN6AD1 compared to SN6AD3. Most disturbances were rated as none/mild.

Adverse Events: No unanticipated serious adverse device effects were observed. Some adverse events were reported but were unrelated to the IOLs.

Color Perception Study: The addition of a proprietary chromophore in the AcrySof® Natural IOL does not negatively affect color vision in patients with normal color vision.

Product Handling: The IOLs are supplied sterile and must be opened under aseptic conditions. The expiration date is clearly indicated, and lenses should be returned if held past this date.

Returned Goods Policy: In the U.S., returned lenses are accepted in exchange for other products, not for credit. A Returned Goods Number is required for returns.

Catalog excerpts

PHYSICIAN LABELING Alcon Laboratories, Inc. STERILE UV and Blue Light Filtering Acrylic Foldable Apodized Diffractive Aspheric Posterior Chamber Intraocular Lenses CAUTION: Federal (U.S.) law restricts this device to sale by or on the order of a physician. DESCRIPTION The AcrySof® IQ ReSTOR® Apodized Diffractive Posterior Chamber Intraocular Lenses (IOLs) are ultraviolet and blue light ltering foldable multifocal intraocular lenses (IOLs). The optical portion consists of a high refractive index material with proprietary blue light ltering chromophore which lters light in a manner that approximates the human crystalline lens in the 400-475 nm blue light wavelength range (Boettner and Wolter, 1962). In addition to standard UV-light ltering, the bluelight ltering chromophore reduces transmittance of blue light wavelengths (see Table 2). The optical portion is symmetric biconvex and consists of a soft acrylic material capable of being folded prior to insertion, allowing placement through an incision smaller than the optic diameter of the lens. After surgical insertion into the eye, the lens gently unfolds to restore the optical performance. The anterior surface of the AcrySof® IQ ReSTOR® IOL Models SN6AD1 and SN6AD3 are designed with negative spherical aberration to compensate for the positive spherical aberration of the cornea. The effect(s) of this aspheric design feature have not been clinically assessed. Figure 1: Physical Characteristics, AcrySof® IQ ReSTOR® IOL Models SN6AD1 (+3.0 D Add) and SN6AD3 (+4.0 D Add) (all dimensions in millimeters)

Open the catalog to page 1

Table 1: Physical Characteristics of AcrySof® IQ ReSTOR® IOLs SN6AD1 (+ 3.0 diopters of add power for near vision) SN6AD3 (+ 4.0 diopters of add power for near vision) Optic Type Apodized Diffractive Aspheric Optics Material Ultraviolet and blue light ltering Acrylate/Methacrylate Copolymer Optic Powers For available base power range see ALCON® Product Guide Haptic Conguration STABLEFORCE® Haptics Haptic Material Haptic Color Haptic Angle 0º Figure 2: Spectral Transmittance Curves (percentage of ultraviolet transmittance) The cutoff wavelength and the spectral transmittance curves presented here...

Open the catalog to page 2

MODE OF ACTION AcrySof® IQ ReSTOR® IOLs are intended to be positioned in the posterior chamber of the eye, replacing the natural crystalline lens. This position allows the lens to function as a refractive medium in the correction of aphakia. This IOL has a biconvex optic containing an apodized diffractive structure that provides increased depth of focus. The aspheric symmetric biconvex optic of the AcrySof® IQ ReSTOR® IOLs are designed to compensate for the positive spherical aberration of the cornea. The effect(s) of this aspheric design feature have not been clinically assessed. The apodized...

Open the catalog to page 3

implantation before attempting to implant intraocular lenses. As with any surgical procedure, there is risk involved. Potential complications accompanying cataract or implant surgery may include, but are not limited to: corneal endothelial damage, infection (endophthalmitis), retinal detachment, vitritis, cystoid macular edema, corneal edema, pupillary block, cyclitic membrane, iris prolapse, hypopyon, transient or persistent glaucoma, and secondary surgical intervention. Secondary surgical interventions include, but are not limited to the following: lens repositioning, lens replacement, vitreous...

Open the catalog to page 4

Overview of AcrySof® IOL CLINICAL STUDIES The various clinical studies listed below have been conducted on AcrySof® Intraocular Lenses. In addition to data from the more recent clinical study of the AcrySof® IQ ReSTOR® IOL, the labeling from the original study of the AcrySof® ReSTOR® IOL is also included in order to provide data intended to help you make an informed decision as to whether or not to implant a multifocal or monofocal IOL (a monofocal IOL was used as a control in the original study). 1. 2. 3. AcrySof® ReSTOR® Apodized Diffractive Optic Posterior Chamber IOL (Models MA60D3 and SA60D3)...

Open the catalog to page 5

Figure 3-B: Combined 20/25 or Better Distance & 20/32 or Better Near Photopic Visual Acuity Binocular, Best Case 6 Months Postoperative Table 3: Cumulative Binocular Photopic Near Visual Acuity by Lens Model, All Implanted, 6 Months Postoperative Sample size N MA60D3 Uncorrected (Best Distance) MA60D3 Best Corrected (Standard Distance) Distance Corrected (Standard Distance) Distance Corrected (Best Distance) MA60D3 Uncorrected (Standard Distance)

Open the catalog to page 6

Table 4: Cumulative Binocular Photopic Distance Visual Acuity by Lens Model, All Implanted, 6 Months Postoperative Sample size Best Corrected Monocular Visual Acuity The following is a summary of monocular visual acuity (VA) results for patients who completed the Form 4 (120-180 days after rst eye implantation), and Form 5 (330-420 days after rst eye implantation) exams. Table 5: Cumulative Monocular Photopic Near Vision by Lens Model, All Implanted, 6 Months Postoperative Sample size MA60D3 Uncorrected (Best Distance) MA60D3 Uncorrected (Standard Distance) Distance Corrected (Best Distance)...

Open the catalog to page 7

Table 6: Cumulative Monocular Photopic Distance Vision by Lens Model, All Implanted, 6 Months Postoperative Sample size Best Corrected *Statistically signicant difference versus monofocal control Table 7: Cumulative Monocular Photopic Near Vision by Lens Model, All Implanted, 1 Year Postoperative Sample size Uncorrected (Best Distance) Uncorrected (Standard Distance) Distance Corrected (Best Distance) Distance Corrected (Standard Distance) Best Corrected (Standard Distance) Table 8: Cumulative Monocular Photopic Distance Vision by Lens Model, All Implanted, 1 Year Postoperative Sample size Best...

Open the catalog to page 8

Figure 4: Mean Defocus Curves by Lens Model, Binocular, All Implanted ® These data demonstrate that the ReSTOR® IOL provides a 4.5 diopter amplitude of functional (20/40 or better) vision (from optical innity to approximately 22 cm). Binocular performance of the ReSTOR® IOL was approximately 0.5 lines better for near vision and 1.5 lines better for intermediate vision than the monocular performance of the ReSTOR® IOL. Additionally, the defocus curves were within 1 line among groups when stratied by pupil size (Figure 5). Figure 5: Mean Defocus Curves by Pupil Size Binocular, All Implanted (N=34)...

Open the catalog to page 9

MODEL SN6AD1

MODEL SN6AD1

Catalog excerpts

All Alcon catalogs and technical brochures