OUYE Deep Plus 1.0ml
OUYE
Medical aesthetic deviceCross-linked hyaluronic acid dermal filler with lidocaine
Certifications
- Hyaluronic acid dermal filler manufactured under medical device quality management systems (e.g. ISO 13485).
- Monophasic, cross Linked HA filler marketed as CE Marked for aesthetic indications in many European and international markets.
- Formulated with minimal residual BDDE and high Purity hyaluronic acid in line with international safety standards for injectable fillers.
- Intended for professional use only in accordance with local medical device and aesthetic treatment regulations.
- Hyaluronic acid dermal filler manufactured under medical device quality management systems (e.g. ISO 13485).
- Monophasic, cross Linked HA filler marketed as CE Marked for aesthetic indications in many European and international markets.
- Formulated with minimal residual BDDE and high Purity hyaluronic acid in line with international safety standards for injectable fillers.
- Intended for professional use only in accordance with local medical device and aesthetic treatment regulations.
Cross-linked hyaluronic acid dermal filler with lidocaine
Description
OUYE Deep Plus 1.0ml is a cross-linked hyaluronic acid dermal filler with lidocaine, designed for deep dermal injections to correct deep wrinkles, folds and areas of significant volume loss. The monophasic, high-viscosity gel provides structural support for facial contouring and volumisation, restoring volume in areas such as the cheeks, nasolabial folds, marionette lines, temples, chin and nose/forehead contour. With 24 mg/ml of highly purified hyaluronic acid and 0.3% lidocaine for patient comfort, OUYE Deep Plus delivers smooth, natural-looking results and long-lasting facial rejuvenation (typically 6–12 months) when administered by trained medical professionals.
Bnefits
- Corrects deep wrinkles and folds, including nasolabial folds and marionette lines.
- Restores facial volume and provides structural support in mid- and deep-dermal layers.
- High-viscosity, monophasic HA gel designed for pronounced lifting, contouring and volumisation.
- 24 mg/ml cross-linked hyaluronic acid provides durable yet natural-looking results.
- Contains 0.3% lidocaine to reduce injection discomfort and improve patient experience.
- Suitable for contouring areas such as cheeks, chin, jawline, nose and forehead.
- High-purity, low-residual-BDDE formulation to enhance safety and biocompatibility.
- Results typically last 6–12 months depending on treatment area, technique and patient factors.
- Supplied in a ready-to-use pre-filled syringe with two sterile 27G needles for convenience.
Indications
- Correction of deep facial wrinkles and folds (e.g. nasolabial folds, marionette lines).
- Restoration of moderate to severe volume loss in the mid- and lower face.
- Facial contouring and volumisation of areas such as cheeks, chin, jawline and temples.
- Non-surgical enhancement of nose and forehead contour in appropriate candidates.
- Patients seeking more pronounced aesthetic improvements and long-lasting volumising results.
- Adults with deep wrinkles and facial volume loss who are suitable candidates for hyaluronic acid dermal filler treatment.
Composition
- Cross-linked hyaluronic acid (sodium hyaluronate) 24 mg/ml.
- Lidocaine hydrochloride 0.3% (3 mg/ml) for local anaesthesia.
- Physiological buffer solution (water for injection, sodium chloride and other excipients as per full IFU).
- Residual cross-linking agent BDDE within internationally accepted safety limits.
Formulation
- Monophasic, high-viscosity, cross-linked hyaluronic acid gel.
- Concentration: 24 mg/ml HA.
- Lidocaine concentration: 0.3% to improve comfort during injection.
- Sterile, pyrogen-free, viscoelastic injectable gel for single-patient use.
- Intended injection depth: mid to deep dermis and/or subcutaneous layer depending on area and indication.
- Esthetic effect duration typically 6–12 months.
Packaging
- One pre-filled, sterile 1.0 ml syringe of OUYE Deep Plus.
- 2 sterile 27G needles (commonly 27G 1/2" / 13 mm) included in the blister pack.
- Sterile blister packaging with tamper-evident seal.
- Outer carton containing product information, batch number and expiry date.
- Package insert with detailed instructions for use, indications, contraindications and precautions.
Usage
- OUYE Deep Plus must only be used by licensed healthcare professionals with appropriate training in injection techniques and dermal fillers.
- Before treatment, obtain a full medical history, assess indications and contraindications, and obtain informed consent.
- Clean and disinfect the treatment area thoroughly according to clinical protocol.
- Attach one of the supplied sterile 27G needles to the pre-filled syringe using aseptic technique and expel any air bubbles.
- Recommended injection depth is mid to deep dermis and/or supraperiosteal/subcutaneous plane, depending on the indication and treatment area.
- Use appropriate techniques such as linear threading, serial puncture, fanning or depot injections tailored to the treatment zone (e.g. nasolabial folds, marionette lines, cheeks, chin, nose/forehead contour).
- Inject slowly with gentle, even pressure while continuously observing the skin response and patient comfort.
- Avoid intravascular injection; aspirate carefully where appropriate and be aware of anatomical danger zones, particularly around the nose, glabella and periorbital region.
- After injection, gently massage the treated area if required to shape and evenly distribute the product, unless contraindicated in specific regions.
- Advise patients to avoid makeup on the treated area for several hours, as well as to avoid extremes of heat or cold, vigorous exercise, sunbeds and alcohol for 24–48 hours post-treatment.
- Dispose of any unused product, needles and syringes as clinical sharps and medical waste in accordance with local regulations.
- Refer to the official package insert for detailed instructions, contraindications, warnings and management of potential complications.
Contraindications
- Hypersensitivity or allergy to hyaluronic acid, lidocaine or other amide-type local anaesthetics, or to any component of the formulation.
- History of severe anaphylactic reactions or multiple severe allergies.
- Presence of active skin infection, inflammation, herpetic lesions or dermatological disease at or near the intended injection sites.
- Autoimmune diseases or immunosuppressive therapy, unless specifically evaluated and cleared by the treating physician.
- Known bleeding disorders or current anticoagulant/antiplatelet therapy that significantly increases bleeding risk (relative contraindication; requires careful risk-benefit assessment).
- Pregnancy and breastfeeding (use is generally not recommended due to lack of safety data).
- History of hypertrophic scarring or keloid formation in the proposed treatment areas.
- Previous permanent or semi-permanent fillers in the treatment area without thorough risk assessment.
- Intravascular injection is strictly contraindicated; avoid injection into blood vessels at all times.
Adverse Effects
- Common, usually transient reactions at injection site: redness (erythema), swelling, tenderness, pain, bruising, itching, firmness or lumps/bumps.
- Temporary alteration of skin colour or slight asymmetry in the early post-treatment period.
- Nodules or palpable irregularities due to uneven product placement or local inflammatory responses.
- Delayed inflammatory reactions or hypersensitivity (swelling, induration, redness) which may require medical management.
- Vascular compromise due to unintentional intravascular injection or compression, potentially leading to blanching, pain, livedo reticularis, tissue ischaemia or necrosis if not promptly recognised and treated.
- Very rare but serious complications such as visual disturbance, blindness or stroke when injected near high-risk areas (e.g. glabella, nose, periorbital region) as reported with hyaluronic acid fillers generally.
- Allergic reactions to lidocaine (local or systemic), including rare risk of anaphylaxis.
- Infection at the injection site if aseptic technique is not strictly followed.
Storage Conditions
- Store between 2°C and 25°C (do not freeze).
- Keep in the original packaging to protect from light and contamination until time of use.
- Do not use after the expiry date printed on the carton and syringe.
- Do not use if the packaging is damaged, if the blister is opened or if the syringe appears cracked or leaking.
- Keep out of sight and reach of children.
- Single-use only; do not resterilise or reuse any remaining product in an opened syringe.
Duration
Clinical effect generally lasts between 6 and 12 months depending on the treatment area, injection technique, dose, and individual patient factors such as metabolism, lifestyle and skin quality. Repeat treatments may be performed to maintain or enhance results following professional assessment.
Onset
Volume restoration and wrinkle correction are visible immediately after injection, with final results typically settling over several days as any initial swelling or erythema subsides.
