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 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.

• Consult instructions for use
• Do not use past indicated date

  WARNING: Note the product “Use By” date specified on the package. Do not use expired products.

• CONTRAINDICATION: 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: 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 fiber optic line and infusion lines must not be pulled as these lines are attached to the back end of the iTrack™ 250A and can be damaged if excessive force is applied. WARNING: 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

• PRECAUTION: This device should be used only by physicians trained in ophthalmic surgery. Knowledge of surgical techniques, proper use of the surgical instruments, and post-operative patient management are considerations essential to a successful outcome. PRECAUTION: Do not use a toothed forceps to handle the Canaloplasty Microcatheter, as damage to the device may occur. PRECAUTION: Do not attempt forceful insertion of the Canaloplasty Microcatheter into Schlemm’s canal. The device should be withdrawn immediately if resistance or an obstruction is encountered. PRECAUTION: Avoid kinking or sharp bending of the Canaloplasty Microcatheter. PRECAUTION: Handle the iTrack™ 250A carefully to avoid damaging the device. PRECAUTION: Do not let the viscoelastic dry at the tip of the microcatheter, as this can cause the microcatheter lumen to become occluded. PRECAUTION: Ensure the fiber optic line is not in a path that can be pulled or tripped on. PRECAUTION: When applicable, remove excess viscoelastic from the eye by irrigation and/or aspiration. PRECAUTION: Do not use the product if it appears to be damaged. PRECAUTION: Dispose of the devices, including the microcatheter and ViscoInjector™, in an appropriately labelled, puncture resistant, sharps container after use. PRECAUTION: Do not pull the black fiber optic line or grab onto the blue hub jacket until the assembly has been fully removed from the packaging to avoid damage.

  OTHER

Primary placement in Germany; available across 14 countries total.

Trade name

iTrack 250A

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.

00893872001059

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.

B-00893872001059

Reference / catalog number

iT-250A

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

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

The Nova Eye Canaloplasty Microcatheter Kit (iTrack™ 250A) consists of an illuminated, flexible microcatheter and Ophthalmic Viscoinjector™. The Canaloplasty Microcatheter is a flexible microcatheter design for catheterization and viscodilation of Schlemm's canal to reduce intraocular pressure in adult patients with open angle glaucoma. The ophthalmic ViscoInjector™ is a manually operated device for precision delivery of small amounts of viscous fluid such as sterile viscoelastic solution in a cartridge. The device are provided sterile and are intended for single use. The iTrack™ 250A is designed to work with the Nova Eye iLumin™ Fiberoptic Illuminator.

Additional information URL

https://nova-eye.com/physicians/itrack/

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

No certificate specifically references this device's Basic UDI-DI.

Certificate health across this manufacturer's portfolio.