Important Information; Description; Indications; Contraindications - MORIA M2 Manual De Instrucciones

5 IMPORTANT INFORMATION

5.1 DESCRIPTION

The M2-M2SU microkeratome is an automated, mechanical, pivoting microkeratome. It has three components:
• a M2 motor (#19326) containing 2 independent motors: one for advancement (rotation), and one
for oscillation
• a metallic suction ring (#19325/xx, 19379/-1)
• a single use plastic head (M2SU) encasing a pre-inserted blade, or a metallic reusable head (M2).
The M2 microkeratome operates with the EVOLUTION 2, 3, and 3E control units (#19350, 19360, 19380).
Please refer to the user guides:
• #65016 (EVOLUTION 2)
• #65038 (EVOLUTION 3)
• #65051 (EVOLUTION 3E serial numbers below 5000)
• #65060 (EVOLUTION 3E serial numbers 5000 and above).

5.2 INDICATIONS

The M2 microkeratome is indicated for the creation of lamellar corneal flaps on patients' eyes when using
M2-M2SU heads in combination with a suction ring in corneas with preoperative pachymetry of 500 microns
or greater, and keratometry between 39 D and 49 D.
During laser in-situ keratomileusis (LASIK), the flap is then lifted to enable photoablation of the stroma with
an excimer laser.

5.3 CONTRAINDICATIONS

Patients who are not candidates for LASIK.
Note: Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to
determine the risk/benefit ratio. Particular attention must be given before performing a keratectomy on a
patient with any of the following conditions:
• preoperative pachymetry under 500 microns
• keratometry under 39 D
• keratometry over 49 D
• inability to withstand a transient rise in intraocular pressure.

5.4 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 M2
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.
• Never pull on the cable connected to the handpiece, and never hold the motor by the cable.

5.5 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 (§ 5.3) and
warnings (§ 5.4) expose patient at higher risk to adverse events.
Note: Additional surgery may be necessary to correct some of these potential adverse events.
#65013-F-02.2017 MORIA
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