Potential Adverse Effects; Precautions - MORIA CBm-ALTK CBSU Manuel Utilisateur

• The heads must be screwed by hand. Do not use tools or pliers. Incorrect assembly can produce an
incomplete or defective cut due to improper oscillation of the blade.
• CB blades (#19333) are compatible with CBm-ALTK heads for artificial chambers.
Head
CBm-ALTK
CBSU for artificial chamber

5.6 POTENTIAL ADVERSE EFFECTS

As with any surgical procedure, there is a risk. As lamellar keratectomy requires the use of a microkeratome,
potential complications include and are not limited to those connected with corneal flaps (incomplete flap,
hole in the flap, epithelial defect, micro-striations on the flap, folds in the flap, etc.).
Improper use and/or deterioration of the product and/or non-observance of contraindications (§ 5.4) or of
warnings (§ 5.5) expose the patient to further adverse effects.

5.7 PRECAUTIONS

• A keratectomy should only be performed by an experienced ophthalmic surgeon who has received
training in the CB microkeratome.
• Pre- and peroperative requirements, including knowledge of surgical techniques, of the head used,
of the choice of ring, assembly and positioning of the microkeratome are important factors in the
optimal use of the system by the surgeon.
Other pre- and peroperative precautions must also be taken:
• PREOPERATIVE:
o Special care must be taken when handling, storing and maintaining the components of the
microkeratome. They must not be knocked or damaged. The CB turbine must be protected during
storage, especially in a corrosive environment.
o Check the label and expiry date on the unopened peelable pack of CBSU heads for artificial chamber
and CBm blades.
o After opening a sterile pack of CBSU heads for artificial chambers, check that the markings on the
heads match the information on the pack label.
o The head, ring, CB turbine and console must be carefully inspected before use. The CBm blades
(after insertion into the head #19170/xxx) and the CBSU blades must always be inspected under a
microscope before use.
o The surgeon must be familiar with the components before using the microkeratome, and must check
that all the necessary parts and instruments are present and correctly assembled before beginning
the surgical procedure. Spare sterile components should be available in case they are needed.
o The selection of the head (and potentially the ring) is an important factor in the success of the
surgery.
• PEROPERATIVE:
o Breakage or misuse of the microkeratome and its components can injure the patient, operating room
staff or damage the donor graft.
o Before using, lubricate the suction ring, the rotating cover, the head and the blade with a physiological
saline solution or any other appropriate ophthalmic solution that is compatible with the components
of the CB.
• POSTOPERATIVE:
o The surgeon's recommendations to the patient should be followed.
Reference
19170/xxx
19178/xxx
CBm blade (#19333)
X
N/A
#65078-B-02.2017 MORIA
7