HumanOptics CUSTOMFLEX ARTIFICIALIRIS Mode D'emploi page 7

• No useful vision or visual potential in the fellow eye, unless the patient has debilitating
visual symptoms, so that the potential benefits of CUSTOMFLEX® ARTIFICIALIRIS
implantation clearly outweigh the risks
• Presence of a condition or finding in the fellow eye that would make it unsafe to
implant a CUSTOMFLEX® ARTIFICIALIRIS prosthesis in the eye to be treated
• Allergy to any of the planned postoperative antibiotic or anti-inflammatory medica-
tions, unless a suitable alternative medication can be prescribed
• Implantation for cosmetic color changes of the iris
• Post-partum women who are nursing or lactating and for whom postoperative
medications are contraindicated
• Patients with gastric ulcers or diabetes mellitus in whom high doses of orally
administered systemic steroids are required postoperatively
• Any other condition that would interfere with the planned surgical procedure to
implant the iris device
6. Warnings
The CUSTOMFLEX® ARTIFICIALIRIS should be used with caution in the following situations:
• A clear natural crystalline lens – Do not implant the CUSTOMFLEX® ARTIFICIALIRIS in
phakic eyes
• The visual potential of the fellow eye cannot be evaluated preoperatively (e.g., poor
visual acuity due to cataract)
• Preoperative IOP > 21 mmHg that is known to be stable and well-controlled with
glaucoma treatment (e.g., medication, tubes or shunts)
• Presence of any other medical condition that might be expected to make the patient an
unsuitable candidate for CUSTOMFLEX® ARTIFICIALIRIS implantation
• Anticipated complexity of the planned surgical procedure that might increase the
potential for complications
• Implantation in the fellow eye before stabilization of the first implanted eye (typically
1 month or more)
The aperture of the CUSTOMFLEX® ARTIFICIALIRIS pupil is fixed at 3.35 mm. In the
event that a larger pupillary opening is required for posterior segment surgery, the
CUSTOMFLEX® ARTIFICIALIRIS can be explanted and a new CUSTOMFLEX® ARTIFICIALIRIS
may be implanted after completion of the posterior segment surgery. The technique for
a secondary implantation would be determined in the same manner as for a primary
implantation.
7. Potential complications and undesirable side effects
Below is a list of the potential complications and undesirable side effects associated with
the use of the device, surgical procedure, or IOL.
Device-related complications associated with the CUSTOMFLEX® ARTIFICIALIRIS may
include but may not be limited to:
• Worsening of photosensitivity and vision
• Elevated intraocular pressure
• Decrease in uncorrected distance visual acuity
• Decrease in best-corrected distance visual acuity
• Eye infection/inflammation
• Incorrect device positioning, dislocation, and decentration
• Secondary (additional) surgical intervention
Surgical repositioning, replacement or removal of the device may be necessary to correct
device dislocations. Device defects can occur if the device is not handled properly.
Surgery-related adverse events may include, but may not be limited to:
• Cystoid macular edema
• Hypopyon
• Endophthalmitis
• Device migration
• Pupillary block
• Retinal detachment
• Secondary surgical intervention (unplanned)
• Corneal edema, persistent at 3 months or later
• Chronic iritis/anterior segment inflammation persistent at 3 months or later
If IOL replacement is performed during the same surgical procedure as the iris implant
surgical procedure, IOL-related complications may include, but may not be limited to:
• Anisometropia
• Glare/halos
• Diplopia
• IOL removal or replacement due to lens power calculation error
8. Clinical benefits
The CUSTOMFLEX® ARTIFICIALIRIS implant has the potential to improve the quality of life
by reducing visual symptoms and improving the cosmetic appearance of the eye.
9. Safety and clinical performance
For products registered under Regulation (EU) 2017/745, the summary of safety and
clinical performance (SSCP) will be published in EUDAMED, the European Database
on Medical Devices, under the URL [https://ec.europa.eu/tools/eudamed]. The
SSCP of the CUSTOMFLEX® ARTIFICIALIRIS is linked in EUDAMED to the Basic UDI-DI
4049154999989. Until the EUDAMED becomes available, the SSCP is located under
www. humanoptics. com.
10. Handling
Before use, check the package for the correct model and the expiration date. The implant
should not be implanted after the indicated expiration date.
Before use, check the integrity of the sterile barrier system. The device is sterile only if
the sterile pouch is undamaged. The implant container may only be opened under sterile
conditions.
To remove the CUSTOMFLEX® ARTIFICIALIRIS, hold the flap of the sealed foil lid of the
container and pull it off. After removing the implant from the container, ensure that the
device surface is free of any adhering particles or any other defects.
Please note that the color of the CUSTOMFLEX® ARTIFICIALIRIS in air versus in saline
solution differs. The actual color of the device in aqueous humor may vary due to the
cornea.
In the event of a malfunction of the device or a change in its performance, please return
the affected product including all available documentation (e.g. labels, packaging)
to your local distributor or the manufacturer. Contact to the manufacturer via email:
complaint@humanoptics.com.
11. Surgical use instructions
11a. Model selection and preparation
The CUSTOMFLEX® ARTIFICIALIRIS is a foldable device that is custom-made for each
individual patient. The CUSTOMFLEX® ARTIFICIALIRIS is available in two models: 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. The selection of the surgical technique should be dictated
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