Nom de l'organisation

Nova Eye, Inc.

SRN

US-MF-000011341

Statut du fabricant

Actif

8 avertissements enregistrés — faire défiler le panneau pour tout voir.

• Ne pas restériliser

  WARNING: The devices in this kit are intended for single use only. Do not re-sterilize and/or reuse, as this can compromise device performance and increase the risk of cross contamination due to inappropriate reprocessing.

• Ne pas utiliser si l’emballage est endommagé

  WARNING: Do not use product if the pouch integrity has been compromised.

• Ne pas réutiliser

  WARNING: The devices in this kit are intended for one time use only. DO NOT re-sterilize and/or reuse, as this can compromise device performance and increase the risk of cross contamination due to inappropriate reprocessing.

• Consulter la notice d’utilisation
• CONTRAINDICATIONS: The Canaloplasty Microcatheter is not intended to be used for catheterization and viscodilation of Schlemm’s canal to reduce intraocular pressure in eyes of patients with the following conditions: • Neovascular glaucoma • Angle-closure glaucoma • Previous surgery with resultant scarring of Schlemm’s canal

  AUTRE

• WARNING: Note the product “Use By” date specified on the package. Do not use expired products. WARNING: Do not use the cannula to create an incision in external tissues. WARNING: Be careful when taking off the protective cap of the cannula to not break sterility by piercing the surgical drapes or gloves of the surgeon or technicians with the exposed cannula. WARNING: In the event of microcatheter damage or breakage, recovery of any portion should be performed based upon physician determination of individual condition and appropriate retrieval protocol. WARNING: The fiberoptic line and infusion line must not be pulled as these lines are attached to the back end of the iTrack™ Advance handle when in use.

  AUTRE

• PRECAUTION: Do not use product if the tamper proof seal has been broken. PRECAUTION: Do not use product if the packaging tray is cracked or broken when pouch is opened. PRECAUTION: Do not remove the protective cover from the cannula until ready to use. PRECAUTION: Handle the iTrack™ Advance carefully to avoid damaging the device. PRECAUTION: Do not use product if the cannula cover is not attached to the handpiece. PRECAUTION: Do not use product if it appears to be damaged PRECAUTION: Do not apply excessive force to the cannula cover or the actuator. PRECAUTION: Do not let the viscoelastic dry at the tip of the microcatheter, as this can cause the lumen to become occluded. PRECAUTION: Ensure the fiberoptic line is not in a path that can be pulled or tripped on. PRECAUTION: Avoid touching the cannula with any surfaces as this may damage the precisely manufactured spatulated tip. PRECAUTION: Do not bend the cannula. PRECAUTION: Do not use excessive force when directing the cannula and maintain visualization of the spatulated tip and microcatheter to avoid contacting and damaging unintended tissues. PRECAUTION: Do not use excessive force when manipulating the spatulated tip to avoid unintended tissue damage PRECAUTION: The microcatheter should be advanced and retracted slowly using the actuator, and the spatulated tip must be positioned correctly to prevent the microcatheter from being kinked or bent. PRECAUTION: Actuator withdrawal and viscoelastic flow must be smooth, consistent, and continuous. PRECAUTION: When applicable, remove excess viscoelastic from the eye by irrigation and/or aspiration.

  AUTRE

• PRECAUTION: Caution: the red light emitted from this instrument is sufficiently low in intensity to pose no hazard to the patient when used correctly in accordance with this instruction for use. Nevertheless, avoid shining light directly from the microcatheter into the pupil of the patient’s eye for periods longer than 5 seconds. It is always good practice to avoid direct staring into the beam of a laser-based instrument.

  AUTRE

Marché principal en Allemagne ; disponible dans 15 pays au total.

Dénomination commerciale

iTrack Advance

Code d'IUD-ID

ID primaire

L'ID primaire est l'IUD-ID principal qu'un fabricant désigne comme identifiant de référence d'un dispositif dans EUDAMED.

00893872001615

IUD-ID de base

IUD-ID de base

L'IUD-ID de base est l'identifiant principal qui regroupe toutes les variantes d'un même modèle de dispositif — la clé de la « famille » réglementaire.

0893872001iTrack-ADSMR

Numéro de référence/catalogue

iTrack-ADS

Entité d'attribution

Entités d'attribution IUD

Les entités d'attribution sont les organismes que la Commission européenne a désignés pour attribuer les identifiants uniques des dispositifs au titre du système IUD de l'UE.

GS1

Catégorie de risque

Classes de risque RDM

Les classes de risque du RDM classent les dispositifs médicaux du risque le plus faible (classe I) au plus élevé (classe III), ce qui détermine le niveau de contrôle réglementaire.

Classe IIa

Législation applicable

MDR [Règlement (UE) 2017/745 relatif aux dispositifs médicaux]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

The iTrack™ Advance, is a sterile, single use system comprised of a Canaloplasty Microcatheter preloaded into an ergonomic Handheld Cannula and supplied with an Ophthalmic ViscoInjector™. • The Canaloplasty Microcatheter is a flexible microcatheter designed for catheterization and viscodilation of Schlemm’s canal to reduce intraocular pressure in adult patients with open angle glaucoma. • The ergonomic Handheld Cannula enables the physician to insert and retract the Microcatheter with a single hand using the actuator on the Handle of the Body to propel the catheter. The Handheld Cannula has a curved and spatulated tip to aid insertion of the microcatheter directly into Schlemm’s canal. • The Ophthalmic ViscoInjector™ permits administration of viscoelastic directly into Schlemm’s canal delivered through the Microcatheter. The iTrack™ Advance is designed to interface to a re-useable endoilluminator (the iLumin™) to illuminate the tip of the microcatheter, providing a visual indication to the surgeon of the position of the microcatheter tip within the canal.

URL des informations complémentaires

https://res.nova-eye.com/ifu/

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• Numéro de lot
• Date d'expiration
• Date de fabrication
• Numéro de série
• Identification du logiciel

Nomenclature européenne des dispositifs médicaux — la classification produit UE attribuée à ce dispositif.

• Q0299OPHTHALMIC DEVICES - OTHER

• Dispositifs médicaux de Classe IIa dans EUDAMED

Santé des certificats sur le portefeuille de ce fabricant.