Organization name

Nova Eye, Inc.

SRN

US-MF-000011341

Manufacturer status

Active

8 warnings recorded — scroll inside the panel to see all entries.

• Do not resterilize

  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.

• Do not use if package is damaged

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

• Do not re-use

  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.

• Consult instructions for use
• 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

  OTHER

• 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.

  OTHER

• 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.

  OTHER

• 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.

  OTHER

Primary placement in Germany; available across 15 countries total.

Trade name

iTrack Advance

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

00893872001615

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

0893872001iTrack-ADSMR

Reference / catalog number

iTrack-ADS

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class IIa

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

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.

Additional information URL

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

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• Q0299OPHTHALMIC DEVICES - OTHER

• Class IIa medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.