MesoEye C71®

MESOEYE C71® injectable gel is a sterile, biodegradable, non-pyrogenic, viscoelastic, transparent, colorless gel intended for facial intradermal injection. MESOEYE C71® is designed for intensive treatment and remediation of under-eye bags, sagging, and dark circles. The proprietary bioactive formulation contains Periorbital Peptide XP2®, Hexapeptide-17, and fermentative hyaluronic acid in a non-crosslinked form, vitamin C, retinol, microelements, a rich array of amino acids, and nucleic acid precursors.

MESOEYE C71® is a non-surgical cosmetic treatment indicated for microvessel perfusion rehabilitation in skin tissue and the correction of age-related facial contour changes around the eye area associated with the development of under-eye bags, sagging and dark circles in adults over the age of 21.

MESOEYE C71® is a single-use device administered by a physician via multiple intradermal microinjections.

• Patients with severe allergies set on by a history of anaphylaxis or history/presence of severe allergies;
• Patients with previous hypersensitivity to hyaluronic acid or intolerance to one or more of the device’s constituents;
• Patients with bleeding disorders;
• Implantation in anatomical spaces other than the dermis.

• Postpone treatment at a site(s) in which an active inflammatory response (skin eruptions such as pimples, rashes, cysts, or hives) or infection is present until the response or infection has been treated.
• Do not implant MESOEYE C71® injectable gel into blood vessels. Take extra care when injecting soft tissue — checking to ensure proper insertion.
• Typical treatment response primarily centers around short-term inflammatory symptoms at the injection site, starting post-treatment and lasting up to three (3) days. Other potential adverse effects reported during post-market surveillance include short-term erythema, edema, pruritus, or moderate soreness in the injection sites. Reference the ADVERSE EVENTS section for more details.

• This device is meant to be used on a single patient in one treatment session. Do not resterilize. Observe sanitary and epidemiological requirements during any invasive procedures. Verify the integrity of the packaging before use. Do not use the device past the indicated shelf life or if the packaging has been damaged;
• The safety and effectiveness of this device for the treatment of the regions below have not been established in controlled clinical studies. During any transcutaneous procedure, there is a risk of infection - standard precautions associated with injectable materials should be adhered to;
• Any and all uses of this device outside of the intended uses or any modification/use outside of the stated Directions For Use may impact the quality, homogeneity, sterility, or performance of the device and its constituents;
• Do not use this device in conjunction with devices of similar nature and/or purpose. Avoid the treatment of similar sites within fourteen (14) days before or after treatment with Botulinum Toxin agent, use of chemical peeling, or laser treatment;
• The safety of this treatment for use in patients during pregnancy, breastfeeding, or in patients under 18 years has not been established. Use with caution in patients on immunosuppressive therapy or patients with bleeding disorders. Avoid site(s) with a permanent implant;
• Patients should avoid taking high doses of Vitamin A or E supplements, aspirin, or nonsteroidal anti-inflammatory medications before treatment as these products may increase bleeding or bruising at the injection site(s);
• Previous acute inflammatory elements (acne, herpes) or chronic skin diseases (cysts, pimples, rashes, or hives) in the area of the potential injection site(s) may experience an inflammatory response or reactivation of herpes;
• Refrain from using saunas or tanning salons while also avoiding direct sunlight between treatment sessions;
• Syringe contents, syringes, and needles must be safely discarded immediately after use to prevent potential biohazards. Dispose of these items per accepted medical guidelines and applicable local or federal requirements;
• MESOEYE C71® should only be used by licensed medical professionals with appropriate training, experience, and knowledge in anatomy at/around the injection site to maintain a safe, sterile, and effective treatment procedure. By encouraging discussion of the potential risks of soft tissue injection with patients before the procedure, clinicians can be sure that patients are aware of the symptoms and signs of potential complications;
• Failing to follow needle attachment instructions may result in needle disengagement or leakage at the LUER-LOK adaptor or connection, failure to adhere to recommended needle size or use of a needle larger than 32G can lead to improper distribution of the device and the formation of large papules.

• After treatment with MESOEYE C71®, reactions related to invasive procedures may occur and continue for 1-3 days. These reactions include redness, swelling, itching, tenderness, and change in skin color at the injection site(s). Other known potential adverse effects reported during post-market surveillance include short-term erythema, edema, pruritus, or moderate soreness in the injection site(s) for 1-3 days.

MESOEYE C71® is supplied in a disposable glass syringe with LUER-LOK™ fitting (needle provided separately), packaged in a vac-formed tray with a Tyvek-film seal. Each packaged preparation contains a disposable one-time-use syringe filled with 1 mL of MESOEYE C71®, directions for use, and a label containing the following information: Device name, syringe volume, lot number, and expiration date.

The provided label is affixed to the patient’s medical record and gives the physician a medical history.

• Store away from sunlight at a temperature of 2 - 25°C.
• Do not freeze, reuse, or resterilize.
• The device must be used before the printed expiration date.

Proper assembly ensures the safe and accurate use of MESOEYE C71® —

• Examining the patient’s medical history is advised to identify indications and contraindications for using soft-tissue injection solutions. Potential allergies can be identified by interviewing the patient and, if necessary, performing allergic and tissue sensitivity testing. Treatment shall be prescribed based on indications and the patient’s age.
• Patients should avoid taking high doses of Vitamin A or E supplements, aspirin, or nonsteroidal anti-inflammatory medications before treatment. These products may increase bleeding or bruising at the injection site(s).
• Do not expose the injection sites to severe cooling (wind, frost) shortly before treatment.
• Refrain from using indoor tanning or sauna/steam baths shortly before treatment.
• Remove any makeup before the procedure.
• Treat the skin three times with a 0.05% chlorhexidine solution before administering MESOEYE C71®.
• The application of local anesthetic cream is permitted if required.

• Ensure that patients are properly counseled and that all potential risks, benefits, and expected outcomes are discussed.
• Assess the patient’s needs for pain management by utilizing the appropriate anesthetic treatment for managing comfort.
• The patient’s face should be washed and treated with alcohol or another antiseptic solution.
• It is recommended to use sterile gloves during invasive procedures to ensure sterility.
• Upon injection, press the syringe rod until any pockets of air escape and a small droplet of the solution is visible at the tip.
• MESOEYE C71® is administered using a thin gauge needle (33G). The needle is introduced to the periorbital area - 1-2 mm deep. The injected amount is 0.05 mL per injection.
• For correction of under-eye dark circles and wrinkles, 0.05 mL volume per injection is prescribed using the superficial micro papule technique whereby the needle is introduced 1-2 mm deep with the bevel oriented upwards along the whole surface of the periorbital region.
• To correct persistent edema in the periorbital region and herniation, 0.1 mL volume per injection is prescribed by injection directly into the herniated sac while pinching with fingers to form a fold whereby the needle is introduced 2-4 mm deep.
• Inject by applying equal pressure along the plunger rod; close attention must be paid to ensure the injection is halted just before the needle is removed from the skin to prevent material from protruding or being injected too superficially.
• Average use per treatment session is dependent on the injection site(s) as well as the amount of correction desired. Based on clinical observations, the maximum recommended dose per session is 1.0 mL per person.

🔻 DO NOT OVERCORRECT 🔻

MICRO-PAPULAR TECHNIQUE

• PERIORBITAL REGION: The needle is introduced parallel to the periorbital skin — 1-2 mm deep; The needle bevel should be oriented upwards in order to improve control over the single injection; The injected amount is 0.05 mL per injection with a distance of 4-5 mm between injection sites.
• For correction of under-eye dark circles and wrinkles, 0.05 mL volume per injection is prescribed using the superficial micro papule technique whereby the needle is introduced 1-2 mm deep with the bevel oriented upwards along the whole surface of the periorbital region.

Recommended Needle:   33G (0.23 x 4mm)

CAUTION: Use of a needle larger than 33G may cause incorrect distribution. Deviation from these methods can lead to pronounced swelling of the treated area.

Fig. 1 — 0.05 mL per injection site

• Do not apply or use decorative cosmetics for 24 hours.
• Do not expose the injection sites to severe cooling, i.e., wind and frost.
• Refrain from using indoor tanning or sauna/steam baths throughout the treatment procedures.
• Refraining from active sports or physical exercise for 48 hours, these stressors can cause temporary redness, swelling, or itching at the injection site(s).
• To report potential adverse effects, please promptly notify ABG LAB at 1-800-682-5741 or [email protected].

• MESOEYE C71® does not include a needle; use extreme caution to avoid sharps exposure. Ensure appropriate usage of referenced needle size.
• To help avoid needle breakage, do not attempt to straighten a bent needle. Discard it and complete the procedure with a replacement needle.
• Do not shield used needles. This practice should be avoided; discard unshielded needles in approved collectors.
• Follow all national, state, local, or institutional guidelines for using and disposing of sharp medical devices. Obtain prompt medical attention if an injury occurs.

Manufactured For

To place an order, please call 1-800-682-5741 or email [email protected].

12/2016 DFU.ME V2 [EN] © 2016 ABG LAB, LLC. All trademarks are the property of their respective owners.