Crystalens Advanced Optics (AO) Accommodating IOL


Crystalens AO IOL is the premium IOL that provides excellent vision quality across a more natural range. As the first and only FDA-approved accommodating IOL, Crystalens AO IOL delivers an active range of vision, excellent contrast sensitivity, and minimized issues with halos and glare across a range of vision that includes functional near, intermediate, and distance vision.1,2

Crystalens AO offers excellent stability and performance. Excellent distance, intermediate, and near visual outcomes were sustained up to 7 years (in a sub-study of patients).3 Moreover, in designing Crystalens AO, the natural crystalline lens was used as a literal road map rather than an artificial model. Pseudophakic accommodation and evidence of forward movement as the primary mechanism of action of Crystalens have been demonstrated in multiple studies using objective and subjective methods.1,2,4

Key Features & Benefits

  • First and only FDA-approved accommodating IOL
  • Provides excellent vision quality across a more natural range
  • Excellent distance, intermediate, and near visual outcomes sustained up to 7 years (in a sub-study of patients)3

Crystalens AO Accommodating IOL Specifications

Model Recommended
Starting
A-Constant
Recommended
Starting ACD
Overall
Diameter
Diopter
Power

Crystalens
AO IOL

AO1UV

located on outside
of package*

located on outside
of package*

 

11.5 mm

+17 D to +33 D
in 0.5-D steps

+17 D to +27 D
in 0.25-D steps

Crystalens
AO IOL

AO2UV

located on outside
of package*

located on outside of
package*

12..0 mm

+4 D to +9 D
in 1.0-D steps

+10 D to +16 D
in 0.5-D steps

+16 D to +27 D
in 0.25-D steps

+27.5 D to +33 D
in 0.5-D steps

 

Optic Diameter  5.0 mm
Shape  Biconvex
Material Biosil (silicone elastomer)

* A-constant and ACD are estimates only. It is recommended that each surgeon develop his or her own values.


INDICATIONS FOR USE

The Crystalens posterior accommodating intraocular lens (IOL) is intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia secondary to the removal of a cataractous lens in adult patients with and without presbyopia. Crystalens provides approximately one diopter of monocular accommodation which allows for near, intermediate, and distance vision without spectacles.

WARNINGS

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. Unlike most other IOLs, the Crystalens AO IOL optic has hinges connecting it to the haptic; please see adverse events section below for more information.

PRECAUTIONS

Do not resterilize this intraocular lens by any method. Do not store lenses at temperatures over 45°C (113°F). Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to decide the benefit/risk ratio before implanting a lens in a patient with conditions as outlined in the Crystalens AO IOL Directions for Use.

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. Vaulting is a post-operative adverse event where the Crystalens AO IOL optic hinges move into and remain in a displaced configuration. If vaulting occurs, please see Directions for Use for a detailed listing of symptoms, information regarding diagnosis, potential causes, and sequelae. Physicians should consider the characteristics of each individual vaulting case prior to determining the appropriate treatment. Data on long-term follow-up after treatment of vaulting is not available.

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.

References:
1. Pepose JS, Qazi MA, Davies J, et al. Visual performance of patients with bilateral vs combination Crystalens, ReZoom, and ReSTOR intraocular lens implants. Am J Ophthalmol. 2007;144(3):347-357.
2. Ang R, Martinez G, Cruz E, Tiongson A, Dela Cruz A. Prospective evaluation of visual outcomes with three presbyopia correcting intraocular lenses following cataract surgery. Clin Ophthalmol. 2013;7:1811-23. doi: 10.2147/OPTH.S49848.
3. D. Michael Colvard, MD, FACS. Long-term Stability of Accommodative IOLS. Ophthalmology Management. 2011.
4. Crystalens Accomodating Posterior Chamber Intraocular Lens Physician Labeling. 2016.

CRS.0015.USA.17