Organization name

HumanOptics Holding AG

SRN

DE-MF-000017892

Manufacturer status

Active

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

• Consult instructions for use
• Do not re-use
• Do not resterilize
• Do not use if package is damaged
• Do not use past indicated date
• MR CONDITIONAL
• Warnings: The ARTIFICIALIRIS should be used with caution in the following situations: • A clear natural crystalline lens – Do not implant the ARTIFICIALIRIS in phakic eyes • The visual potential of the fellow eye cannot be evaluated preoperatively (e.g., poor visual acuity due to cataract) • Preoperative IOP > 21 mmHg that is known to be stable and well-controlled with glaucoma treatment (e.g., medication, tubes or shunts) • Presence of any other medical condition that might be expected to make the patient an unsuitable candidate for ARTIFICIALIRIS implantation • Anticipated complexity of the planned surgical procedure that might increase the potential for complications • Implantation in the fellow eye before stabilization of the first implanted eye (typically 1 month or more) The aperture of the ARTIFICIALIRIS pupil is fixed at 3.35 mm. In the event that a larger pupillary opening is required for posterior segment surgery, the ARTIFICIALIRIS can be explanted and a new ARTIFICIALIRIS may be implanted after completion of the posterior segment surgery. The technique for a secondary implantation would be determined in the same manner as for a primary implantation.

  OTHER

• Contraindications: The ARTIFICIALIRIS is not to be used for purely cosmetic reasons. The device is contraindicated in eyes with any of the following conditions: • Children who are less than 6 years of age because their eyes are still in a stage of major growth development that would be disrupted by ocular surgery • Uncontrolled ocular inflammation (e.g. uveitis) • Severe chronic uveitis • Microphthalmus • Untreated retinal detachment • Untreated chronic glaucoma • Rubella cataract • Rubeosis of the iris • Proliferative diabetic retinopathy • Stargardt's retinopathy • Pregnancy • Intraocular infections

  OTHER

Primary placement in Germany; available across 32 countries total.

Trade name

Artificial Iris with Fiber Standard Light Brown

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.

04049154178124

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.

04049154_AI_M1_H1_O1_X7

Reference / catalog number

00095231

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 IIb

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

—

Additional information URL

No additional information URL provided by the manufacturer.

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.

• P0399OCULAR PROSTHESES - OTHER

• Class IIb medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.