Warnings; Potential Adverse Events; Precautions - MORIA 65005 Manuel Utilisateur

5.5 WARNINGS

• Single-use devices should not be re-used. Doing so will negatively affect their clinical
performance and increase the potential for adverse events.
• Do not use disposable materials and/or components of a brand other than MORIA with the CB
microkeratome.
• Blades must only be inserted in heads by hand. Never use any tools or spanners. Incorrect assembly
may cause incomplete or uneven cuts due to lack of blade oscillation.
• The heads must only be screwed on by hand. Never use any tools or other spanners. Incorrect
assembly may cause incomplete or uneven cuts due to lack of blade oscillation.
• CBm blades (#19333) are compatible with CB heads (#19307/xxx) and CBm heads (#19332/xxx).

5.6 POTENTIAL ADVERSE EVENTS

As with any surgical procedure, there is risk involved. LASIK surgery requiring the use of a microkeratome
that cuts a corneal flap, potential side effects of laser refractive surgery may include but are not limited to:
visual anomalies, dry eye and flap related complications (free cap, incomplete flap, buttonhole, epithelial
defect, flap dislocation, flap striae, wrinkles, etc.).
Inappropriate use, deterioration of microkeratome and/or non-respect to contraindications (§ 5.4) and
warnings (§ 5.5) expose patient at higher risk to adverse events.
Note: Additional surgery may be necessary to correct some of these potential adverse events.

5.7 PRECAUTIONS

• The keratectomy must be performed only by experienced refractive surgeons with specific training in
the use of the CB-CBm-CBSU microkeratome.
• Preoperative and operative procedures, including knowledge of surgical techniques, proper head
and ring selection, and assembly and placement of the microkeratome are important considerations
in the successful use of the system by the surgeon. Furthermore, the proper patient selection and
compliance will greatly affect the results.
For USA only
CAUTION: FEDERAL LAW (USA) RESTRICTS THESE DEVICES TO SALE BY OR ON THE ORDER OF
A PHYSICIAN.
Other preoperative, intraoperative, and postoperative warnings and precautions are as fellows:
• PREOPERATIVE:
o Only patients that meet the criteria described in the indications should be selected.
o Care should be used in the handling and storage of the microkeratome components. They should not
be scratched or otherwise damaged. The CB turbine should be protected during storage, especially
from corrosive environments.
o Check the label and expiration date on unopened packages of CBSU heads and CBm blades.
o After opening the sterile package of CBSU heads, verify that head information is consistent with
information on outer package labeling.
o The head, suction ring, CB turbine, and the control unit should be fully inspected prior to use. The
blade should be inspected on both sides under a microscope.
o The surgeon should be familiar with the various components before using the microkeratome and
verify that all parts and necessary instruments are present and properly assembled before the
surgery begins. Additional sterile components should be available in case of an unexpected need.
o The selection of the proper head, ring, and stop position for each eye is crucial to the success of the
procedure: see MORIA nomogram (#65026).
6
MORIA #65005-F-02.2017
System
CB
CBm
CBSU
Head
19307/xxx
19332/xxx
19312/xxx
CBm blade (#19333)
Compatible
Compatible
Not compatible