Akreos family of IOLs provide a flexible platform to deliver an aberration-free optic with square edge design1

One family, Two designs, Three sizes, Four point haptic design1

  • Manufactured to allow for an incision size as small as 1.8mm2
  • Available in three lengths (10.5, 10.7, 11.0mm) for excellent fit2
  • Four point haptic design for excellent centration and stability2
  • The equi-biconvex Akreos design with its low refractive index material minimizes reflected light2


Akreos Specifications

Model Recommended
Starting
A-Constant
Overall
Diameter
Diopter
Powers
Delivery
System

Akreos MICS
M160L

119.1*

11.0 mm (+0 to +15 D)
10.7 mm (+15.5 to +22 D)
10.5 mm (+22.5 to +30 D)

+0 D to +9 D in 1.0 D steps
+10 D to +30 D in 0.5 D steps

VIS100

Akreos AO
AO60

118.5*

11.0 mm (+0 to +15 D)
10.7 mm (+15.5 to +22 D)
10.5 mm (+22.5 to +30 D)

+0 D to +9 D in 1.0 D steps
+10 D to +30 D in 0.5 steps

VIS100
AI-28
INJ100

Incision Size  As small as 1.8 mm
Optic Shape  Aspheric
Material - Optic and Haptics Hydrophilic Acrylic with UV Blocker
Refractive Index at 35°C  1.458

*A-constants are optical biometry estimates only. It is recommended that each surgeon develop his or her own values.



INDICATIONS

Akreos posterior chamber intraocular lenses are indicated for primary implantation for correction of aphakia in adult patients in whom a cataractous lens has been removed by phacoemulsification. The lens is intended for placement in the capsular bag.

CONTRAINDICATIONS

Implantation is not advisable when the IOL may aggravate an existing condition, interfere with the diagnosis or treatment of a pathology, or present a risk to the sight of the patient. These conditions are uncontrolled glaucoma, rubeotic cataract, retinal detachment, atrophy of the iris, microphthalmia, developing chronic eye infections, endothelial corneal dystrophy, perioperative complications (such as vitreous loss, hemorrhage, etc), foreseeable post-operative complications.

PRECAUTIONS

Do not resterilize these lenses. Do not reuse the IOL. Do not store the device in direct sunlight or at a temperature below freezing (<0°C). Store at room temperature. Avoid high temperatures (>45°C). Do not implant the IOL if the outer pouch or vial is opened or damaged. Do not reuse the IOL. Do not soak or rinse lenses in solutions other than balanced salt solution or equivalent. The IOL should be used in the shortest possible time after opening the vial. Do not implant the IOL if the lens is not completely immersed in solution under any vial orientation. Akreos lenses can absorb substances that they contact (disinfectant, drug). Do not place the lens in contact with surfaces where such contamination can occur. If YAG laser posterior capsulotomy is performed, assure that the laser beam is focused slightly behind the posterior capsule.

WARNINGS

Physicians considering lens implantation under any of the following circumstances should weigh the potential risk/benefit ratio: Patients with recurrent severe anterior or posterior segment inflammation or uveitis; patients in whom the intraocular lens may affect the ability to observe, diagnose or treat posterior segment diseases; surgical difficulties at the time of cataract extraction, which may increase the potential for complications (e.g., persistent bleeding, significant iris damage, uncontrolled positive pressure or significant vitreous prolapse or loss); a compromised eye due to previous trauma or developmental defect in which appropriate support of the IOL is not possible; circumstances that would result in damage to the endothelium during implantation; suspected microbial infection; patients in whom neither the posterior capsule nor the zonules are intact enough to provide support for the IOL; children under the age of 2 years are not suitable candidates for intraocular lenses. Since the clinical study for the Akreos intraocular lens was conducted with lens being implanted in the capsular bag, there is insufficient clinical data to demonstrate its safety and efficacy for placement in the ciliary sulcus. YAG posterior capsulotomies should be delayed until at least 12 weeks after the implant surgery. The posterior capsulotomy opening should be kept as small as possible. There is an increased risk of lens dislocation and/or secondary surgical intervention with early or large capsulotomies. Improper handling many cause damage to the haptic or optic portions of Akreos foldable lenses. If lenses are not handled appropriately, optic tears may result. Physicians should not attempt to implant lenses that have radial optic tears or separations at the optic/haptic interface. Use of folding instruments other than those validated and recommended in the labeling might result in IOL damage (optic tears, haptic damage) that might require IOL explantation. To avoid the creation of permanent forceps marks in the central optic zone, exercise care during handling and insertion of the lens.

ADVERSE EVENTS

The incidence of adverse events experienced during the clinical trial was comparable to or lower than the incidence reported in the historic control (“FDA grid”) population. As with any surgical procedure, risk is involved. The most frequently reported cumulative adverse event that occurred during the clinical trial of the Akreos® was cystoid macular edema, which occurred at a rate of 1.4%. Persistent adverse events included macular edema (0.3%) and iritis (0.3%), which comparable to or lower than the incidence reported in the historic control (“FDA grid”) population, as well as corneal edema (0.9%) and raised IOP requiring treatment (0.6%), which were higher than the incidence reported in the FDA grid.

ATTENTION: Refer to the Directions for Use labeling for a complete listing of indications, warnings and precautions, clinical trial information, etc.

CAUTION: Federal (USA) law restricts this device to the sale by or on the order of a physician.

1. Akreos DFU
2. Data on file


AKR.0021.USA.17