CE Marked injectable facial implant (dermal filler) classified as a medical device in applicable EU/UK markets
Manufactured under Allergan Aesthetics’ ISO 13485 Compliant medical device quality management system
Supplied with Instructions for Use, patient information and implant card consistent with current medical device regulations
CE Marked injectable facial implant (dermal filler) classified as a medical device in applicable EU/UK markets
Manufactured under Allergan Aesthetics’ ISO 13485 Compliant medical device quality management system
Supplied with Instructions for Use, patient information and implant card consistent with current medical device regulations
Latex Free, sterile, apyrogenic single Use device with validated manufacturing, sterilisation and packaging processes
Hybrid HA/CaHA dermal filler with lidocaine
Description
HArmonyCa Lidocaine 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 gel. Supplied as two pre-filled syringes (commonly 2 x 1.25 ml) containing 0.3% lidocaine for patient comfort, it is intended for facial soft tissue augmentation in adults and should be 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, helping to restore skin architecture, firmness and elasticity in patients with facial volume loss and laxity.
Bnefits
Dual-effect hybrid injectable that combines hyaluronic acid for immediate lift with calcium hydroxyapatite microspheres for sustained collagen stimulation and long-term support
Intended for facial soft tissue augmentation with visible improvement in volume, contour and overall skin quality
Designed for patients experiencing loss of facial elasticity and volume, particularly in the mid and lower face
Ready-to-use, pre-filled syringes with no need for reconstitution, improving convenience and workflow in clinic
Contains 0.3% lidocaine hydrochloride to reduce pain during injection and enhance patient comfort
Can provide a true instant lift that is maintained over many months, with ongoing collagen-mediated improvements
Helps restore skin quality attributes such as firmness and elasticity for a rejuvenated appearance
Sterile, pyrogen-free, latex-free and biodegradable injectable implant manufactured under medical device quality standards
Indications
Facial soft tissue augmentation in adults (18 years and over)
Treatment of age-related facial volume loss and loss of elasticity in the mid and lower face
Improvement of contour and projection in areas such as cheeks, jawline and chin within recommended treatment zones
Patients seeking combined immediate lifting with longer-term collagen-stimulating effects
Adjunctive treatment in broader facial rejuvenation plans when used by appropriately trained clinicians
Synthetic calcium hydroxyapatite microspheres homogeneously suspended in a cross-linked hyaluronic acid gel matrix
Latex-free, biodegradable implant intended for deep dermal and sub-dermal injection in specific facial regions
Contains 0.3% lidocaine for local analgesia during treatment
Packaging
Carton containing 2 single-use pre-filled glass syringes (each approximately 1.25 ml) of HArmonyCa Lidocaine
Two sterile, thin-walled, single-use 27G 1/2" needles for injection
Instructions for Use (IFU) and patient documentation / implant card in accordance with medical device regulations
Each syringe labelled with batch/lot number and expiry date for full traceability
Usage
HArmonyCa Lidocaine is for use only by suitably trained and qualified healthcare professionals experienced in dermal filler and deep-tissue injection techniques.
Before use, carefully read the full Instructions for Use (IFU), including indications, contraindications, warnings, precautions and detailed injection guidance.
Inspect outer packaging and syringes; do not use if blisters, syringes or seals are damaged, or if the gel appears discoloured or contains visible particulate matter inconsistent with the product description.
Maintain strict aseptic technique. Clean and disinfect the treatment area thoroughly prior to injection.
Attach the supplied sterile 27G 1/2" needle firmly to the syringe luer connection, prime the needle and expel air before injection.
Inject only into the deep dermal or sub-dermal layers of appropriate facial regions, avoiding high-risk anatomical areas and any zones contraindicated in the IFU.
Inject slowly in small aliquots, advancing with care and maintaining awareness of anatomical structures; aspirate in accordance with local practice where appropriate to reduce the risk of inadvertent intravascular injection.
Distribute the product evenly following the recommended injection patterns and volumes for each facial zone, taking care not to overcorrect.
After injection, gently mould or smooth the treated areas if needed and as tolerated by the patient, avoiding excessive pressure.
Provide patients with post-treatment advice, including information on common short-term reactions (e.g. swelling, redness, bruising), and instruct them to avoid extreme temperature exposure, vigorous exercise and manipulation of the treated areas for the period recommended in the IFU.
Single use only; do not resterilise. Dispose of any unused product, syringes, needles and associated materials in approved sharps and clinical waste containers in line with local regulations.
Contraindications
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 or chronic skin disease, infection or inflammation at, or in the vicinity of, the intended injection sites
Patients with a history of severe allergic reactions or anaphylaxis to injectable implants or local anaesthetics
Patients with known bleeding disorders or those receiving significant anticoagulant or antiplatelet therapy where bleeding risk cannot be adequately managed by the clinician
Patients prone to keloid formation or hypertrophic scarring in the proposed treatment area
Pregnant or breastfeeding women (generally not recommended due to lack of safety data)
Use in minors under 18 years of age
Injection into high-risk anatomical regions (e.g. periocular, glabellar or certain nasal areas) or into blood vessels, as specified in the IFU and current best-practice guidelines
Adverse Effects
Common and usually transient injection-site reactions including redness (erythema), swelling, tenderness, pain, warmth and bruising
Localised itching or discomfort at or near the injection site
Formation of palpable or visible nodules, papules, indurations or irregularities in the treated area
Asymmetry or uneven correction if product distribution is suboptimal
Rare events such as local infection, abscess formation or delayed inflammatory / granulomatous reactions
Rare but serious complications associated with dermal fillers, including inadvertent intravascular injection leading to tissue ischaemia, necrosis or visual disturbance; these require immediate recognition and appropriate management by the treating practitioner
Other adverse reactions typical of injectable HA/CaHA implants as outlined in the official IFU
Storage Conditions
Store in the original blister/carton to protect from light and contamination until use.
Keep refrigerated or at controlled room temperature within the range specified in the IFU, typically between 2°C and 25°C; do not freeze.
Avoid exposure to excessive heat, direct sunlight or temperature extremes.
Do not use after the expiry date printed on the packaging and syringe labels.
Keep out of the sight and reach of children.
Duration
The visible lifting and volumising effect from the HA component is immediate, with collagen-stimulating benefits from the CaHA microspheres typically maintained for many months; clinical and promotional sources describe maintained improvement for around 12\u201318 months or longer, depending on patient factors, treatment area and injector technique.
Onset
Immediate volumising and lifting effect due to the hyaluronic acid gel, followed by progressive improvement in skin architecture, firmness and elasticity over weeks to months as new collagen is produced around the CaHA microspheres.
