Precautions; Products Complaints; Packaging - MORIA Epi-K Benutzerhandbuch

5.6 PRECAUTIONS

• Epi-LASIK must be performed only by experienced refractive surgeons with specific training of the
Epi-K™ epikeratome.
• Preoperative and operating procedures, including knowledge of surgical techniques, suction ring
and stop selection, assembly and placement of the epikeratome are important considerations in
the successful use of the system by the surgeon. Furthermore, proper patient selection and his
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 who meet the criteria described in the indications should be selected.
o Care should be used in the handling and storage of the epikeratome components. They should not
be scratched or otherwise damaged. Handpieces should be protected during storage, especially
from corrosive environments.
o Check the label and expiration date on the unopened package of heads and rings.
o After opening the package, verify that head and ring information is consistent with information on
outer package labelling.
o The head, suction ring, handpiece and control unit should be fully inspected prior to use. Both
surfaces of the pre-inserted separator should be inspected under a microscope.
o The surgeon should be familiar with the various components before using the epikeratome 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 ring and stop position for each eye is crucial to the success of the
procedure.
• INTRAOPERATIVE
o Breakage, slippage, or misuse of epikeratome and its components may cause injury to the patient
or operating personnel.
o Before any usage and during the whole epithelial flap creation, lubricate the eye, the suction ring,
the head and separator with a physiological saline solution or another appropriate ophthalmic
solution that is compatible with the Epi-K™ components.
• POSTOPERATIVE
o The surgeon's postoperative instructions to the patient and the corresponding patient compliance
are extremely important.

5.7 PRODUCTS COMPLAINTS

Health care professionals (e.g., customers or users of this device) having any complaints about or
dissatisfaction with the product quality, identity, durability, reliability, safety, effectiveness and/or performance,
should notify MORIA or its distributor by telephone, fax or written correspondence, and have the products
checked by MORIA.
When filing a complaint, please provide the component(s) name(s), reference(s), batch number(s), as well as
your name and address, the nature of the complaint, and the relevant patient data. Also disinfect and return
the components.

5.8 PACKAGING

Packages of each of the components should be intact upon receipt. If a loaner or consignment system is
used, all sets should be carefully checked for completeness, and all components should be carefully checked
to ensure that there is no damage prior to use.
Damaged packages or products should not be used and should be returned to MORIA.
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MORIA #65044-B-02.2017