CE Marked injectable facial implant (dermal filler) under applicable EU/UK medical device regulations
Manufactured under Allergan Aesthetics’ ISO 13485 Compliant quality management system for medical devices
Sterile, apyrogenic, latex Free single Use medical device with validated manufacturing, sterilisation and packaging processes
CE Marked injectable facial implant (dermal filler) under applicable EU/UK medical device regulations
Manufactured under Allergan Aesthetics’ ISO 13485 Compliant quality management system for medical devices
Sterile, apyrogenic, latex Free single Use medical device with validated manufacturing, sterilisation and packaging processes
Includes patient and practitioner information leaflets and implant card in line with MDR requirements in relevant markets
Hybrid HA/CaHA dermal filler with lidocaine
Description
HArmonyCa Lidocaine (2 x 1.25ml) is a dual-effect hybrid dermal filler from Allergan Aesthetics that combines calcium hydroxyapatite (CaHA) microspheres with cross-linked hyaluronic acid (HA) in a single injectable implant. Supplied as two prefilled 1.25ml syringes containing 0.3% lidocaine for patient comfort, it is intended for facial soft tissue augmentation in adults and is injected into the deep dermal and sub-dermal layers. The HA component provides an immediate lifting and volumising effect, while the CaHA microspheres stimulate endogenous collagen production over time, improving skin architecture, firmness and long-lasting support in the mid and lower face.
Bnefits
Dual-effect hybrid filler combining hyaluronic acid for immediate lift with CaHA microspheres for long-term collagen stimulation
Designed for facial soft tissue augmentation with visible improvement in volume, contour and skin quality
Deep dermal and sub-dermal placement supports mid and lower face lifting and structural support
Contains 0.3% lidocaine hydrochloride to reduce pain during injection and improve treatment comfort
Provides gradual, sustained results as new collagen forms around the CaHA microspheres
Latex-free, bio-degradable dermal implant supplied sterile and apyrogenic in prefilled syringes
Can be used in appropriately selected patients as an alternative or complement to traditional HA fillers and stand-alone biostimulators
Indications
Facial soft tissue augmentation in adults (18+)
Improvement of volume loss and contour deficiencies in the mid and lower face
Support and lift of areas affected by age-related laxity and structural decline
Enhancement of skin architecture, firmness and elasticity through collagen stimulation
Patients seeking a combination of immediate lifting with longer-term biostimulatory effects
Synthetic calcium hydroxyapatite microspheres embedded in a cross-linked hyaluronic acid gel carrier
Latex-free, bio-degradable implant intended for deep dermal and sub-dermal use in specific facial regions
Pre-filled, graduated 1.25 ml glass syringes with 0.3% lidocaine
Packaging
Box containing 2 pre-filled 1.25 ml glass syringes of HArmonyCa Lidocaine
2 single-use 27G 1/2" thin-wall sterile needles
Instructions for Use (IFU) and patient information materials as supplied by Allergan Aesthetics
Usage
For professional use only by suitably trained and qualified healthcare practitioners experienced in dermal filler injection techniques.
Carefully review the full Instructions for Use (IFU) before treatment, including indications, contraindications, warnings and injection guidelines.
Inspect the packaging and syringes; do not use if the blister, syringe or security seals are damaged, or if the contents appear discoloured or contain particulate matter inconsistent with the product description.
Clean and disinfect the treatment area using appropriate aseptic technique prior to injection.
HArmonyCa Lidocaine is intended for injection into the deep dermal and sub-dermal layers of specific facial regions; do not inject superficially or into unintended anatomical areas.
Attach the supplied sterile 27G 1/2" needle securely to the syringe, ensuring the luer connection is tight and free of leaks, then expel air and prime the needle.
Inject slowly using small aliquots, advancing with care while aspirating in accordance with local practice where appropriate to reduce the risk of inadvertent intravascular injection.
Distribute the product evenly according to the treatment plan, respecting facial anatomy, depth and recommended techniques described in the IFU.
After injection, gently mould or smooth the treated area if required and as tolerated by the patient; avoid excessive pressure.
Provide post-treatment advice, including information on possible short-term reactions (swelling, redness, bruising) and guidance on avoiding extreme temperature exposure, strenuous exercise and manipulation of the treated areas for the period recommended by the manufacturer.
Do not resterilise; single-use only. Any unused product, used needles and syringes must be disposed of in accordance with local biohazard and sharps regulations.
Contraindications
Known hypersensitivity or allergy to any component of the product, including hyaluronic acid, calcium hydroxyapatite, lidocaine hydrochloride, other amide-type local anaesthetics or gram-positive bacterial proteins
Presence of active skin disease, infection or inflammation (acute or chronic) at or near the intended injection sites
Patients who are prone to keloid formation, hypertrophic scarring or significant inflammatory skin disorders in the treatment area
History of severe allergic reactions or anaphylaxis to injectable implants or local anaesthetics
Untreated epilepsy or porphyria as listed in clinical consent documentation for HArmonyCa treatment
Pregnancy or breastfeeding (use is generally not recommended due to lack of safety data)
Known coagulation disorders or ongoing anticoagulant/antiplatelet therapy where the bleeding risk cannot be adequately managed by the treating clinician
Injection into high-risk anatomical regions (such as periorbital, glabellar and certain nasal areas) is contraindicated or strongly discouraged as per the IFU and current best practice
Adverse Effects
Common, usually transient injection-site reactions including redness, swelling, tenderness, pain, warmth and bruising
Itching or localised discomfort at or near the injection site
Formation of palpable or visible nodules, papules or indurations in the treated area
Asymmetry, irregularity or uneven correction if the product is not evenly distributed
Rare events such as infection, abscess formation or delayed inflammatory reactions
Rare but serious complications associated with dermal fillers, including intravascular injection leading to tissue ischaemia, necrosis or visual disturbance, require immediate recognition and management by the treating practitioner
Potential migration of material if injected into or near contraindicated regions (for example, reports of material migration into the lips when injected incorrectly)
Storage Conditions
Store in the original packaging to protect from light and contamination until use.
Maintain storage at controlled room temperature within the range specified in the official IFU; do not freeze.
Do not expose to excessive heat, direct sunlight or extremes of temperature.
Do not use after the expiry date printed on the packaging and syringe label.
Keep out of the sight and reach of children.
Duration
Clinical effects typically persist beyond those of standard hyaluronic acid fillers, with collagen-mediated benefits generally maintained for many months; published and promotional materials describe sustained improvement for approximately 12\u201318 months or more, depending on patient factors, treatment plan and injector technique.
Onset
Immediate visible lifting and volumising effect due to the hyaluronic acid gel carrier, followed by progressive improvement in skin architecture and firmness over weeks to months as new collagen forms around the CaHA microspheres.
