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Restylane Eyelight Lidocaine 1 x 0.5 ml

Restylane Eyelight Lidocaine 1 x 0.5 ml

Restylane

Injectable Medical Device
  • CE Marked hyaluronic acid dermal filler for aesthetic use in applicable markets according to European medical device regulations.
  • Manufactured using non Animal stabilized hyaluronic acid (NASHA technology) in compliance with relevant quality and safety standards for sterile injectable medical devices.
  • Subject to pharmacovigilance and device vigilance systems, including national adverse event reporting schemes where applicable.
Hyaluronic Acid Dermal Filler

Description

Restylane Eyelight with Lidocaine is a sterile, transparent, biodegradable, cross-linked hyaluronic acid (HA) dermal filler specifically designed to treat the infraorbital (tear trough) area. Using NASHA technology, it has a firmer gel texture to provide targeted and precise product placement for infraorbital hollows, dark under-eye shadows and periorbital volume loss. The filler consists of non-animal stabilized HA at 20 mg/mL with 0.3% lidocaine hydrochloride in phosphate buffered saline, supplied in a 0.5 ml pre-filled glass syringe. It is injected by qualified healthcare professionals to restore volume in the preorbital/tear trough region, soften fine to moderate periorbital wrinkles and reduce the appearance of dark circles, resulting in a refreshed and less tired look.

Bnefits

  • Specifically formulated for the periorbital and tear trough area to correct infraorbital hollowing and dark under-eye shadows.
  • Restores volume in the preorbital region, reducing hollows and improving light reflection for a brighter, less tired appearance.
  • NASHA technology provides a firm, targeted gel with precise placement and minimal, controlled spread, ideal for the delicate under-eye area.
  • Helps smooth fine to moderate wrinkles and lines around the eyes (periorbital wrinkles and fine lines).
  • Contains 0.3% lidocaine to reduce injection pain and improve patient comfort during treatment.
  • Non-animal, stabilized hyaluronic acid gel with established safety profile and reversibility.
  • 0.5 ml syringe volume is optimized for under-eye treatment and controlled correction.
  • Long-lasting results, with many patients maintaining improvement for up to about 9–12 months depending on individual factors.
  • Produced by Galderma as part of the Restylane portfolio, with strong clinical backing and regulatory approval (including FDA approval for infraorbital hollowing in adults over 21).

Indications

  • Improvement of infraorbital hollowing in adult patients (tear trough deformity).
  • Correction of volume loss in the preorbital / periorbital area.
  • Reduction of dark circles and shadows under the eyes caused by volume deficit.
  • Softening of fine to moderate wrinkles and lines around the eyes (periorbital wrinkles and fine lines), when appropriate for the gel’s properties.
  • Use only by appropriately trained and legally authorised healthcare professionals, in accordance with the official Instructions for Use and local regulations.

Composition

  • Non-animal stabilized hyaluronic acid (sodium hyaluronate), 20 mg/mL.
  • Lidocaine hydrochloride, 3 mg/mL (0.3% lidocaine).
  • Phosphate buffered saline (approximately pH 7).
  • Crosslinking agent: BDDE (1,4-butanediol diglycidyl ether) used to stabilize the hyaluronic acid gel.
  • Clear, transparent, sterile, biodegradable gel free from animal proteins.

Formulation

  • Sterile, transparent, cross-linked gel of non-animal stabilized hyaluronic acid at 20 mg/mL with integrated 0.3% lidocaine hydrochloride in phosphate buffered saline, manufactured using NASHA technology and supplied in a single-use, pre-filled 0.5 ml glass syringe for subcutaneous and/or supraperiosteal injection in the periorbital region as described in the Instructions for Use.

Packaging

  • 1 x 0.5 ml pre-filled glass syringe of Restylane Eyelight with Lidocaine.
  • Supplied as a single-use sterile syringe in an individual blister pack.
  • Typically supplied with compatible sterile disposable needles (needle gauge and length as stated on the packaging and IFU; often in the 27–30G range depending on market).
  • Syringe equipped with luer-lock fitting and tamper-evident cap.
  • Outer carton printed with product name, volume (0.5 ml), batch number, and expiry date.
  • Patient record and traceability labels provided on the syringe/carton for placement in medical records.

Usage

  • For professional use only: Restylane Eyelight must be administered exclusively by appropriately trained and legally authorised healthcare professionals familiar with periorbital anatomy and dermal filler injection techniques.
  • Before use, inspect the outer carton, blister and syringe. Do not use if packaging is damaged, sterile barrier is compromised, or the product is past its expiry date.
  • Obtain a full 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 procedures or implants in the treatment area.
  • Prepare and disinfect the treatment area according to local clinical protocols for injectable procedures.
  • Attach a suitable sterile needle or cannula of the recommended gauge and length to the luer-lock syringe using aseptic technique, and expel air from the system prior to injection.
  • Restylane Eyelight is generally injected into the subcutaneous fatty tissue and/or supraperiosteal plane in the infraorbital/tear trough region, as directed in the official Instructions for Use, avoiding intravascular or intramuscular injection.
  • Inject slowly using minimal pressure, aspirating carefully before each injection or bolus to reduce the risk of intravascular placement. Use small aliquots and incremental techniques to achieve gradual correction rather than overfilling.
  • Gently mould or massage the treated area if necessary to ensure even distribution and a smooth contour, avoiding excessive pressure over the infraorbital region.
  • Do not inject into areas with active skin disease, inflammation, or infection. Stop the injection immediately if the patient experiences severe pain, blanching, visual changes, or other signs suggestive of vascular compromise, and manage 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 exposure to extreme heat or cold, sunbeds, saunas and strenuous exercise for a short period as per clinic protocol.
  • Record the product name, volume, batch number, injection sites and injected volumes in the patient’s medical record, using the patient traceability labels provided.

Contraindications

  • Severe allergies manifested by a history of anaphylaxis or presence of multiple severe allergies.
  • Known hypersensitivity to hyaluronic acid, lidocaine, other amide-type local anaesthetics, or any of the excipients, including gram-positive bacterial proteins.
  • Bleeding disorders or current significant anticoagulant, thrombolytic or high-dose antiplatelet therapy where injection-related bleeding risk is considered unacceptable.
  • Active skin disease, inflammation, infection or lesions (such as rashes, hives, acne, cysts or herpes lesions) at or near the intended treatment site; treatment should be deferred until healing is complete.
  • Injection into blood vessels or intravascular injection is strictly contraindicated; injection into muscle is also contraindicated.
  • Patients with a history of 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 below the minimum age specified in the product labelling and local regulations (typically adults over 21 years for infraorbital indications).

Adverse Effects

  • Common transient injection-site reactions such as redness (erythema), swelling, tenderness, pain, itching and bruising.
  • Localized lumps, bumps, nodules or palpable irregularities in the treated area.
  • Hematoma or ecchymosis at or near the injection site, particularly in patients with increased bleeding tendency or on anticoagulant/antiplatelet therapy.
  • Temporary altered sensation or numbness in the treated area, partly due to lidocaine and injection trauma.
  • Localized inflammatory reactions, including swelling and redness, which may occur immediately or be delayed; these are usually mild to moderate and self-limiting.
  • Infection at or near the injection site if aseptic technique is not strictly observed.
  • Rare but serious complications associated with inadvertent intravascular injection, including vascular occlusion, ischemia, tissue necrosis or visual disturbance/vision loss.
  • Hypersensitivity or allergic reactions, including rare severe or anaphylactic reactions in susceptible individuals.
  • Delayed nodules, granulomatous reactions or persistent inflammatory responses, which may require medical management.
  • Post-inflammatory hyperpigmentation or other changes in skin pigmentation, particularly in patients with darker skin types, and potential asymmetry or unsatisfactory cosmetic outcome requiring adjustment.

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 packaging and Instructions for Use.
  • Do not freeze; avoid extreme heat or cold and protect from 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

Clinical improvement in infraorbital hollowing and under-eye shadows typically lasts up to about 9\u201312 months, depending on individual metabolism, treatment technique and the extent of correction; some patients may require earlier touch-up or repeat treatment as determined by the treating clinician.

Onset

Volume restoration and reduction of hollows are usually visible immediately after injection, with the final aesthetic result becoming apparent once initial swelling and redness have resolved, typically within several days up to about 2 weeks.

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