HumanOptics CUSTOMFLEX ARTIFICIALIRIS Mode D'emploi page 6

Instructions for use
CUSTOMFLEX® ARTIFICIALIRIS
These instructions for use are for the following models:
MODEL
CUSTOMFLEX® ARTIFICIALIRIS With Fiber
CUSTOMFLEX® ARTIFICIALIRIS Fiber Free
1. Description
The CUSTOMFLEX® ARTIFICIALIRIS device is a foldable iris prosthesis that is custom-made
for each individual patient and is used for the treatment of iris defects in eyes which are
pseudophakic, aphakic or requiring cataract extraction. The CUSTOMFLEX® ARTIFICIALIRIS
prosthesis is manufactured from a commercially available ophthalmic silicone and is
delivered in a blister fi lled with isotonic saline solution. Colorized silicone paste is applied
by hand in a pattern to match the color of the natural iris using a photograph of the
existing iris or, in the case of aniridia, the color of the photograph selected by the patient.
This custom color-match provides a cosmetically acceptable aesthetic restoration with
high patient satisfaction.
The CUSTOMFLEX® ARTIFICIALIRIS device is manufactured as a full 360° iris pros thesis
with an overall diameter of 12.8 mm, which can be trephined as needed to custom-fi t the
device for placement in the posterior chamber (ciliary sulcus or capsular bag).
The device is available in two diff erent variants: With Fiber or Fiber Free. The two models
are identical in every respect, except that the With Fiber model has an embedded
polyester meshwork layer to provide adequate strength to avoid tearing when suturing.
However, the With Fiber model is stiff er and more diffi cult to fold than the Fiber Free one.
Fig. 1: Anterior view of a CUSTOMFLEX® ARTIFICIALIRIS (left), cross section with dimensions
of the models With Fiber (middle) and Fiber Free (right)
For further information regarding the specifi cation of the CUSTOMFLEX® ARTIFICIALIRIS
please visit www.humanoptics.com.
2. Mode of action / operating principle
The CUSTOMFLEX® ARTIFICIALIRIS functions as an iris prosthesis. It has a fi xed aperture
of 3.35 mm, with an opaque perimeter and a black posterior surface to absorb light
completely, reducing photic phenomena. The device closely mimics the appearance of
the natural iris and at the same time reduces the symptoms associated with aniridia. The
small central aperture might increase visual acuity, depth of fi eld, and contrast sensitivity
(pinhole eff ect).
3. Material
The CUSTOMFLEX® ARTIFICIALIRIS is made of a medical-grade hydrophobic silicone
elastomer consisting of diphenyl co dimethyl polysiloxane and silicone reinforcing
resin. For colorization inorganic pigments are used. The model With Fiber is addition-
en
DESIGN
Silicone elastomer with meshwork
Silicone elastomer without meshwork
0.25 0.25
0.40 0.40
ally reinforced by an embedded polymer fi ber meshwork consisting of polyethylene
terephthalate (PET).
4. Intended use
4a. Indications
The CUSTOMFLEX® ARTIFICIALIRIS is indicated for the treatment of full or partial aniridia
resulting from congenital aniridia, acquired defects, or other conditions associated with
full or partial aniridia.
4b. Intended purpose
The CUSTOMFLEX® ARTIFICIALIRIS is intended for use as an iris prosthesis for the
treatment of iris defects in eyes which are pseudophakic, aphakic or requiring cataract
extraction. The device is intended for implantation in the posterior chamber (ciliary
sulcus or capsular bag).
4c. Intended patient population
The CUSTOMFLEX® ARTIFICIALIRIS is indicated for use in adults and children for the
treatment of full or partial aniridia resulting from congenital aniridia, acquired defects, or
other conditions associated with full or partial aniridia.
4d. Intended users
The CUSTOMFLEX® ARTIFICIALIRIS must be handled by health professionals and
implanted by specially trained and certifi ed ophthalmic surgeons (see point 20. Further
requirements for usage).
4e. Contraindications
The CUSTOMFLEX® ARTIFICIALIRIS device is contraindicated in eyes with any of the
following conditions:
• Uncontrolled ocular infl ammation (e.g. uveitis)
• Severe chronic uveitis
• Microphthalmus
• Untreated retinal detachment
• Untreated chronic glaucoma
• Rubella cataract
• Rubeosis of the iris
• Proliferative diabetic retinopathy
• Stargardt's retinopathy
• Pregnancy
• Intraocular infections
5. Caution
Implantation of the CUSTOMFLEX® ARTIFICIALIRIS is not recommended in patients with
the following conditions and situations:
• Children who are less than 6 years of age because their eyes are still in a stage of major
growth development that would be disrupted by ocular surgery
• Preoperative intraocular pressure (IOP) above 21 mmHg that does not respond to
pressure-lowering medication, unless the IOP above 21 mmHg is due to a known
underlying condition that is wellcontrolled with glaucoma treatment, such as ocular
hypertension or open-angle glaucoma
• Patients with severe endothelial corneal dystrophy, because the surgical procedure to
implant the CUSTOMFLEX® ARTIFICIALIRIS may damage the cornea suffi ciently so that
the potential benefi ts of implantation do not outweigh the risks
• The CUSTOMFLEX® ARTIFICIALIRIS is not designed for placement in the anterior chamber
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