00095162

Organization name

HumanOptics Holding AG

SRN

DE-MF-000017892

Manufacturer status

Active

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

• CW999

  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
• CW010

  EUDAMED did not publish a description for this code.
• CW009

  EUDAMED did not publish a description for this code.
• CW001

  EUDAMED did not publish a description for this code.
• CW007

  EUDAMED did not publish a description for this code.
• CW032

  EUDAMED did not publish a description for this code.
• CW026

  EUDAMED did not publish a description for this code.
• CW999

  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.

Primary placement in Germany; available across 32 countries total.

Trade name

not provided

UDI-DI code

04049154169443

Basic UDI-DI

04049154_AI_M1_H1_O1_X7

Reference / catalog number

00095162

Issuing entity

GS1

Risk category

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.

• P0399OCULAR PROSTHESES - OTHER

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