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5 IMPORTANT INFORMATION
5.1 DESCRIPTION
The One Use-Plus microkeratome is used to create corneal, lamellar, hinged flaps (keratectomy).
The One Use-Plus microkeratome is an automated, mechanical, linear microkeratome designed to create
nasal-hinged flaps. It has three components:
•
a handpiece (#19345), containing 2 independent motors: one for advancement, and one for
oscillation.
•
a single-use suction ring. A dedicated nomogram has been developed for One Use-Plus with
plastic rings (#65041).
•
a single-use plastic head encasing a pre-inserted blade.
The One Use-Plus microkeratome operates with the EVOLUTION 3 and 3E control units (#19360, 19380).
Please refer to user guide:
•
#65038 (EVOLUTION 3)
•
#65051 (EVOLUTION 3E serial numbers below 5000)
•
#65060 (EVOLUTION 3E serial numbers 5000 and above).
5.2 INDICATIONS
The One Use-Plus microkeratome is indicated for the creation of lamellar nasal-hinged flaps in corneas with
preoperative pachymetry of 500 microns or greater, and keratometry between 39 D and 48 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 48 D
•
inability to withstand a transient rise in intraocular pressure.
5.4 WARNINGS
Design of this medical device does not allow its reuse. Reusing this medical device affects
•
its clinical performances and exposes the patient to adverse events.
•
Do not mix One Use-Plus heads with Epi-K™ components of a brand other than MORIA with the
One Use-Plus microkeratome.
•
Do not mix heads and rings from separate sterile packs. Each disposable head must be used with
the disposable ring from the same pack.
•
The heads must only be screwed on by hand. Dismantling should be done only with the provided
wrench (#19345C) or 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.
Document Aletiq : Rév. J-05.2023 (Validée)
#65039-J-05.2023
5
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