| DESCRIPTION | AR40M | AR40E | AR40e |
|---|---|---|---|
OPTIC CHARACTERISTICS | |||
Power: | -10.0 D to +1.5 D in 0.5 diopter increments | +2.0 D to +5.5 D in 0.5 diopter increments | +6.0 D to +30.0 D in 0.5 diopter increments |
Diameter: | 6.0 mm | 6.0 mm | 6.0 mm |
Shape: | Biconvex Meniscus | Biconvex Meniscus | Biconvex |
Material: | UV-blocking hydrophobic acrylic | UV-blocking hydrophobic acrylic | UV-blocking hydrophobic acrylic |
Edge Design: | OptiEdge™ with 360° square edge, and round anterior edge | OptiEdge™ with 360° square edge, and round anterior edge | OptiEdge™ with 360° square edge, and round anterior edge |
OPTICAL BIOMETRY* | |||
A-Constant (SRK/T): | 118.7 | 118.7 | 118.7 |
AC Depth (HofferQ): | 5.41 mm | 5.41 mm | 5.39 mm |
Surgeon Factor (Holl.1): | 1.63 mm | 1.63 mm | 1.62 mm |
APPLANATION ULTRASOUND BIOMETRY | |||
A-Constant:† | 118.4 | 118.4 | 118.4 |
Theoretical AC Depth: | 5.2 mm | 5.2 mm | 5.2 mm |
Surgeon Factor: | 1.45 mm | 1.45 mm | 1.45 mm |
HAPTIC CHARACTERISTICS | |||
Overall Length: | 13.5 mm | 13.5 mm | 13.0 mm |
Style: | Modified C | Modified C | Modified C |
Material: | 60% Blue Core Polymethylmethacrylate (PMMA) Monofilament | 60% Blue Core Polymethylmethacrylate (PMMA) Monofilament | 60% Blue Core Polymethylmethacrylate (PMMA) Monofilament |
Angle: | 5* | 5* | 5* |
RECOMMENDED INSERTION INSTRUMENTS | MODEL | MODEL | MODEL |
The UNFOLDER™ Emerald XL Series Handpiece | EMERALDXL | EMERALDXL | EMERALDXL |
The UNFOLDER™ Emerald XL Series Cartridge | EMERALDC30 | EMERALDC30 | EMERALDC30 |
*Measurement from the ULIB website. http://www.augenklinik.uni-wuerzburg.de/ulib/c1.htm. The A-Constants listed in the ULIB table were derived from and are only valid for measurements with the Zeiss IOL Master, calculated from patient data on file (as of October 22, 2013).†A-Constant theoretically derived for ultrasound biometry.
INDICATIONS and IMPORTANT SAFETY INFORMATION for SENSAR™ FOLDABLE IOL with OPTIEDGE™ DESIGN, MODELS AR40E, AR40e, and AR40M
RX Only
INDICATIONS
SENSAR Foldable IOLs with OptiEdge Design are indicated for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag.
PRECAUTION
Do not resterilize the lens. Most sterilizers are not equipped to sterilize the soft acrylic material without producing undesirable side effects. Do not reuse lens. Do not soak or rinse the intraocular lens with any solution other than sterile balanced salt solution or sterile normal saline. Do not store the lens in direct sunlight or at a temperature greater than 113°F (45°C). Do not autoclave the intraocular lens. Please refer to the specific instructions for use provided with The UNFOLDER™ Implantation System for the amount of time the IOL can remain in the cartridge before the IOL must be discarded. When The UNFOLDER™ Emerald Series Implantation System is used improperly, the haptics of the SENSAR lens may become crimped or broken. Please refer to the specific instructions for use provided with The UNFOLDER Emerald Series Implantation System.
WARNINGS
Physicians considering lens implantation under any of the following circumstances should weigh the potential risk/benefit ratio:
1. Recurrent severe anterior or posterior segment inflammation or uveitis.
2. Patients in whom the intraocular lens may affect the ability to observe, diagnose, or treat posterior segment diseases.
3. Surgical difficulties at the time of cataract extraction that might increase the potential for complications (e.g., persistent bleeding, significant iris damage, uncontrolled positive pressure, or significant vitreous prolapse or loss).
4. A distorted eye due to previous trauma or developmental defect in which appropriate support of the IOL is not possible.
5. Circumstances that would result in damage to the endothelium during implantation.
6. Suspected microbial infection.
7. Children under the age of 2 years are not suitable candidates for intraocular lenses.
8. Patients in whom neither the posterior capsule nor zonules are intact enough to provide support.
9. Lenses <4.0D are not intended, nor should they be used, for a clear lens exchange.
10. Special consideration should be given to the dimensions of lenses at the extreme end of the power range (<4.0D) in relation to the anatomical clearances in the patient's eye. The potential impact of factors such as optic central thickness, optic edge thickness, and overall lens size on the patient's long-term clinical outcome should be carefully weighed against the potential benefit associated with the implantation of an intraocular lens. The patient's clinical progress should be carefully monitored.
11. Johnson & Johnson Surgical Vision Inc. IOLs are single-use medical devices that are labeled with instructions for use and handling to minimize exposure to conditions that may compromise the product, patient, or the user. The reuse/resterilization/reprocessing of Johnson & Johnson Surgical Vision Inc. single-use medical devices may result in physical damage to the medical device, failure of the medical device to perform as intended, and patient illness or injury due to infection, inflammation, and/or illness due to product contamination, transmission of infection, and lack of product sterility. Since the clinical study of the Model AR40 was conducted with the lens being primarily implanted in the capsular bag only, there are insufficient clinical data to demonstrate its safety and efficacy for placement in the ciliary sulcus.
ADVERSE EVENTS
The most frequently reported adverse event that occurred during the clinical trials of the lens was anterior lens tissue on growth, which occurred at a rate of 11.3%. Other reported adverse events include macular edema at 0.8%, and endophthalmitis, lens dislocation, hypopyon, and secondary surgical intervention at 0.3%.
ATTENTION
Reference the Directions for Use labeling for a complete listing of indications and important safety information.
PP2023CT5300
