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Restylane Lido Eyelight (1 x 0.5 ml)

Restylane Lido Eyelight (1 x 0.5 ml)

Restylane

Injectable Medical Device
  • CE Marked hyaluronic acid dermal filler for aesthetic use in applicable markets under European medical device regulations.
  • Manufactured using non Animal stabilized hyaluronic acid (NASHA technology) and BDDE crosslinking under medical device quality and safety standards.
  • Subject to regulatory post Market surveillance and adverse event reporting (device vigilance) in countries where it is marketed.
Hyaluronic Acid Dermal Filler

Description

Restylane Lido Eyelight (Restylane Eyelight with Lidocaine) is a hyaluronic acid (HA) dermal filler from Galderma specifically designed for treatment of the under-eye (tear trough) and periorbital region. It is a clear, transparent, viscous gel of non-animal stabilized hyaluronic acid (NASHA technology) at 20 mg/mL, cross-linked with BDDE and combined with 0.3% lidocaine hydrochloride to improve patient comfort during injection. The product is intended to restore volume in the infraorbital hollows, soften fine lines and folds around the eyes, and reduce the tired appearance caused by volume loss under the eyes. It is supplied as a sterile, single-use 0.5 ml pre-filled glass syringe for injection by trained medical professionals.

Bnefits

  • Specifically developed as an under-eye (tear trough) filler to reduce hollows and shadows and give a less tired appearance.
  • Restores lost volume in the infraorbital region, improving light reflection and brightening the eye area.
  • NASHA technology provides a firm, targeted gel with controlled spread and moderate lifting capacity, suitable for precise work in the periorbital area.
  • Helps reduce fine lines, wrinkles and folds caused by volume loss, including tear troughs, smile lines and other mid-face areas when used appropriately.
  • Contains 0.3% lidocaine to reduce injection pain and enhance patient comfort during the procedure.
  • Non-animal stabilized hyaluronic acid with a high degree of crosslinking (5/5) for durability and predictable performance.
  • Moderate volume effect and firm gel texture help support the delicate infraorbital tissues without excessive bulk.
  • Single-use, sterile packaging with recommended fine-gauge needles optimised for periorbital injections.

Indications

  • Facial tissue augmentation for aesthetic purposes in adults, performed by trained healthcare professionals.
  • Treatment of infraorbital hollows (tear trough deformity) and volume loss under the eyes to reduce a tired appearance.
  • Correction of fine lines, wrinkles and folds in the periorbital area (mid dermis / supraperiosteal zone).
  • Treatment of moderate lines and folds such as nasolabial folds, glabellar lines, frown lines, smile lines and marionette lines where the gel’s firmness and lifting capacity are appropriate.
  • Use in midface and jawline areas with adequate soft tissue support via deeper subcutaneous or supraperiosteal injection when indicated and consistent with the Instructions for Use.

Composition

  • Cross-linked sodium hyaluronate (hyaluronic acid), 20 mg/mL (non-animal stabilized, NASHA technology).
  • Lidocaine hydrochloride, 3 mg/mL (0.3% lidocaine).
  • Phosphate buffered saline, pH ~7, q.s. to 0.5 ml.
  • Crosslinking agent: BDDE (1,4-butanediol diglycidyl ether).
  • Clear, transparent, viscous, biodegradable gel free from animal proteins.

Formulation

  • Sterile, clear, transparent and viscous injectable gel of non-animal stabilized, cross-linked hyaluronic acid at 20 mg/mL with 0.3% lidocaine hydrochloride in phosphate buffered saline (pH ~7), produced using NASHA technology with high crosslinking degree (5/5), moderate lifting capacity and firm gel texture, supplied as a 0.5 ml pre-filled glass syringe for dermal and periorbital use.

Packaging

  • Single-use glass syringe containing 0.5 ml of Restylane Lido Eyelight gel.
  • Blister pack presentation with one pre-filled syringe per box.
  • Supplied with 29G 1/2" thin wall needle(s); a 25G Steriglide cannula may also be used as recommended.
  • Pack may contain one or more 29G TW or 30G needles as per local configuration.
  • Outer carton labelled with product name, volume, batch number, expiry date and manufacturer details.
  • Traceability / patient record labels affixed to syringe or carton for placement in medical records.

Usage

  • For strict medical use only: Restylane Lido Eyelight must be administered exclusively by dermatologists, aesthetic physicians or other appropriately trained and authorised healthcare professionals in accordance with local regulations.
  • Before use, inspect the outer carton, blister and syringe to ensure integrity and verify the expiry date; do not use if packaging is damaged or the product is expired.
  • Obtain a complete medical history including allergies (especially to hyaluronic acid, lidocaine or other amide-type local anaesthetics and gram-positive bacterial proteins), bleeding disorders, autoimmune disease and previous aesthetic treatments or implants in the intended treatment area.
  • Prepare the treatment area by cleansing and disinfecting the skin according to clinical protocols for injectable procedures.
  • Attach a recommended needle (e.g. 29G 1/2" thin wall) or compatible sterile cannula (e.g. 25G Steriglide) to the luer-lock syringe using aseptic technique; expel any air from the system before injection.
  • For tear trough and periorbital treatment, inject into the mid dermis and/or supraperiosteal plane in the peri-orbital zone, or into subcutaneous fatty tissue for areas with adequate soft tissue cover, as described in the product information.
  • Inject slowly using minimal pressure, aspirating carefully before each injection or bolus to reduce the risk of intravascular placement; use small aliquots and incremental placement to avoid overcorrection.
  • Gently mould or massage the treated area if necessary to ensure even distribution and a smooth contour, avoiding excessive pressure on the delicate infraorbital tissues.
  • Do not inject into areas with active infection, inflammation or skin disease. If the patient experiences severe pain, blanching, visual disturbance or other signs of vascular compromise, stop the injection immediately and initiate appropriate management according to current clinical guidelines.
  • After treatment, advise the patient to avoid touching or applying makeup to the treated area for several hours and to avoid extreme temperatures, sunbeds, saunas and strenuous exercise for a short period as per clinic protocol.
  • Record product name, batch number, injection sites, injected volumes and any immediate reactions in the patient’s medical record, using the supplied traceability labels.

Contraindications

  • Severe allergies manifested by a history of anaphylaxis or a history or presence of multiple severe allergies.
  • Known hypersensitivity to hyaluronic acid, lidocaine, other amide-type local anaesthetics, BDDE or any of the excipients, including gram-positive bacterial proteins.
  • Bleeding disorders or current significant use of anticoagulant, thrombolytic or high-dose antiplatelet therapy where injection-related bleeding risk is considered unacceptable.
  • Active skin or mucosal disease, inflammation, infection or lesions at or near the intended injection site (e.g. dermatitis, acne, rashes, herpes).
  • Intravascular injection is strictly contraindicated; the product must not be injected into blood vessels.
  • Intramuscular injection is contraindicated; product is intended for dermal, subcutaneous or supraperiosteal injection as specified.
  • Patients with a known tendency to hypertrophic scarring or keloid formation should generally not be treated with dermal fillers.
  • Use during pregnancy or breastfeeding is not recommended due to insufficient safety data.
  • Use in patients under 21 years of age for infraorbital hollowing and under the minimum legal/advised age specified in local regulations and product labelling.

Adverse Effects

  • Common, usually transient injection-site reactions including redness, swelling, tenderness, pain, itching, bruising and mild erythema.
  • Localized lumps, bumps, nodules or palpable irregularities at or near the injection site.
  • Hematoma or ecchymosis, particularly in patients with an increased tendency to bruise or on anticoagulant/antiplatelet therapy.
  • Temporary changes in sensation such as numbness, tingling or tightness in the treated area due to lidocaine and injection trauma.
  • Localized inflammatory reactions such as swelling and redness, which may appear immediately or be delayed and usually resolve spontaneously.
  • Infection at or near the injection site if aseptic technique is not strictly followed.
  • Rare delayed inflammatory reactions, granuloma formation or persistent nodules requiring additional medical management.
  • Rare but serious complications associated with inadvertent intravascular injection, including vascular occlusion, ischemia, tissue necrosis or visual disturbance/vision loss, which require urgent medical attention.
  • Post-inflammatory hyperpigmentation or other pigment changes, particularly in patients with darker skin types.
  • Unsatisfactory cosmetic outcome or asymmetry that may necessitate further treatment, adjustment or product dissolution with hyaluronidase.

Storage Conditions

  • Store in the original outer carton to protect from light and maintain sterility until use.
  • Store at controlled temperature, typically between 2°C and 25°C, as indicated on the product packaging.
  • Do not freeze; avoid exposure to excessive heat and direct sunlight.
  • Do not use after the expiry date printed on the syringe and carton.
  • Do not use if the sterile blister or syringe packaging is opened or damaged before use.

Duration

Typical duration of effect is approximately 9 to 12 months in the treated area, depending on individual metabolism, treatment area, injection technique and volume used.

Onset

Volume restoration and reduction of under-eye hollows are usually visible immediately after injection, with final results evident once initial swelling and redness have subsided, typically within several days up to about 2 weeks.

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