HumanOptics CUSTOMFLEX ARTIFICIALIRIS Mode D'emploi page 9

After the preparation ex-vivo of the sutures for the fixation to the scleral wall, the iris
device should be folded for implantation with forceps with the colored side outward.
The leading edge of the folded device should be placed in the ciliary sulcus and allowed
to unfold with the edges of the implant oriented posteriorly, so that contact with the
corneal endothelium is minimized. The iris device can be manipulated either with hooks
or with a micro-grasping small-gauge intraocular forceps to facilitate the positioning.
The iris device should be placed within the ciliary sulcus, and an adequately snug fit
should be confirmed. If the iris device appears to buckle or fits too tightly, it should
be removed, trephined to a smaller size, and then reinserted. If the iris device is freely
mobile, then the sutures should be passed and tightened to achieve good centration of
the device. Overtightening of the sutures could lead to ovalization of the pupil, distortion
of the device. Once acceptable centration and stability are confirmed, the OVD can be
removed. Removal of the OVD using a bimanual approach may help to maintain a deep
chamber and avoid dislocation of the artificial iris. The incision should be sealed and
secured according to surgeon preference. Instillation of intraocular carbachol is advised
to reduce the risk of postoperative pressure elevation. Patch graft material can be placed
over fixation sutures, as deemed necessary by the operating surgeon.
12e. Sulcus placement of the iris device and Posterior-chamber IOL (PCIOL) with
suture fixation to the scleral wall
Only the CUSTOMFLEX® ARTIFICIALIRIS With Fiber model can be used for this surgical
technique.
The suture fixation of both a PCIOL and iris device can be achieved using one of three
methods:
1) Fixation of the iris device to the PCIOL ex vivo on the surgical field, then the PCIOL-iris
device complex is affixed by using non-absorbable sutures passing through the scleral
wall with these sutures affixed to the IOL portion of the complex;
2) Fixation of the iris device to the PCIOL ex vivo on the surgical field, then the PCIOL-iris
device complex is affixed by using non-absorbable sutures passing through the scleral
wall with these sutures affixed to the iris device portion of the complex; or,
3) The PCIOL and iris device can be independently fixated to the scleral wall using non-
absorbable sutures, either placed through same scleral wall openings or separate
scleral wall openings.
Note: Gluing the CUSTOMFLEX® ARTIFICIALIRIS to the IOL is not a recommended method
to achieve fixation.
13. MRI safety status
The CUSTOMFLEX® ARTIFICIALIRIS devices containing the maximal amount of magnetic
pigments were tested according to ASTM Standards F2052-15:2015, F2119-07:2013,
F2182-11a:2011 and F2213-17:2017.
Non-clinical testing has demonstrated the CUSTOMFLEX® ARTIFICIALIRIS is MR
Conditional. A patient with this device can be safely scanned in an MR system meeting
the following conditions:
• Static magnetic field of 1.5 Tesla, 3 Tesla and 7 Tesla
• Maximum spatial field gradient of 200 G/cm (2 T/m)
• Maximum MR system reported, whole body averaged specific absorption rate (SAR) of
2 W/kg (normal Operating Mode)
Care has to be taken when moving the patient inside and outside the imaging area,
because spatial field gradients for almost all scanners are higher than the limits defined
here. However, these higher spatial field gradients could affect the patient only for a
very short period of time (a few seconds) and for a very short distance (within a few
centimeters).
Under the scan conditions defined above, the CUSTOMFLEX® ARTIFICIALIRIS device is
expected to produce a maximum temperature rise of less than 2.0°C after 15 minutes
of continuous scanning.
In non-clinical testing, the image artifact caused by the device extends approximate ly
24.2 mm from the CUSTOMFLEX® ARTIFICIALIRIS when imaged with a gradient echo pulse
sequence and a 7 Tesla MR system.
If the MRI scan can only be performed under different conditions than the above-
mentioned ones, it is recommended that the patient sees the treating ophthalmologist
after the examination.
This information is also available on the website www.humanoptics.com/mri.
14. Reprocessing
The CUSTOMFLEX® ARTIFICIALIRIS is for single-use only. Reprocessing or re-steriliza tion
of the CUSTOMFLEX® ARTIFICIALIRIS is strictly prohibited, and may compromise device
performance, which could cause serious harm to the patient's health and safety.
15. Disposal in accordance with national and local regulations
Discarded CUSTOMFLEX® ARTIFICIALIRIS devices (used or unused) are classified as medical
or clinical waste due to their potentially infectious nature and must be disposed of
accordingly in accordance with national and local regulations.
16. Patient information
A patient card is included in the package of every product. Enter the patient data on the
patient card and apply the self-adhesive label containing the product identification to
the designated space on the card. Instruct the patient to keep this card as a permanent
record and to show it to any eye care professional consulted in the future. For further
patient information please visit www.humanoptics.com/patient-information.
17. Lifetime of the CUSTOMFLEX® ARTIFICIALIRIS
Once implanted, the CUSTOMFLEX® ARTIFICIALIRIS implant remains permanently in the
patient's eye. Due to the mechanical, optical and biocompatible material properties of
the CUSTOMFLEX® ARTIFICIALIRIS, the device is expected to be stable indefinitely over
the lifetime of the patient.
18. Reporting
Serious incidents should be reported to HumanOptics and to the relevant competent
authorities.
19. Disclaimer
The manufacturer is not liable either for the implantation method or the operative
technique used by the physician performing the procedure or for the selection of the
CUSTOMFLEX® ARTIFICIALIRIS in relation to the patient or his/her condition.
Furthermore, the manufacturer is not liable for a postoperative difference in color
between the natural iris tissue and the iris implant.
20. Further requirements for usage
A high level of surgical skill and experience in the field of anterior segment surgery is
required for CUSTOMFLEX® ARTIFICIALIRIS implantation. Before the first implantation,
the surgeon must have successfully completed the OCC (Online Certification Course) by
HumanOptics. Each participant receives a certificate number, which is required to proceed
with the product order.
EU law restricts this device to practitioners who have been trained and have experience in
the surgical management and treatment of aniridia and iris defects.
The CUSTOMFLEX® ARTIFICIALIRIS is restricted to sale by or on the order of a physician or
any other health entity.
9