Precautions; Product Complaints; Packaging - MORIA One Use-Plus Benutzerhandbuch

5.6 PRECAUTIONS

• The keratectomy must be performed only by experienced refractive surgeons with specific training
in the use of the One Use-Plus 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, 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
• Only patients that meet the criteria described in the indications should be selected.
• Care should be used in the handling and storage of the microkeratome components. They should
not be scratched or otherwise damaged. Handpiece should be protected during storage, especially
from corrosive environments.
• Check the label and expiration date on the unopened package for head.
• After opening the package, verify that head information is consistent with information on outer
package labeling.
• The head, suction ring, handpiece and the control unit should be fully inspected prior to use. The
pre-inserted blade should be inspected on both sides under a microscope.
• 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.
• The selection of the proper head, ring and stop position for each eye is crucial to the success of
the procedure: see MORIA nomogram.
INTRAOPERATIVE
• Breakage, slippage, or misuse of microkeratome and its components may cause injury to the
patient or operating personnel.
• Before any usage, lubricate the eye, the suction ring, the head and the blade with a physiological
saline solution or another appropriate ophthalmic solution that is compatible with the One Use-
Plus components.
POSTOPERATIVE
• The surgeon's postoperative instructions to the patient and the corresponding patient compliance
are extremely important.

5.7 PRODUCT 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. Do not use single-use products if package is open or torn.
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MORIA #65040-F-02.2017