00083100

Organization name

HumanOptics Holding AG

SRN

DE-MF-000017892

Manufacturer status

Active

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

• 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.
• CW999

  Contraindications: Outside of general contraindications of ocular surgery, there are no specific contraindications for the IOLs covered by the instructions for use.
• CW999

  Warnings: - Due to the hydrophilic properties of the material, substances such as disinfectants, antibiotics or viscoelastics can theoretically be absorbed by the lens. This may lead to a toxic lens syndrome. Therefore, at the end of surgery, care should be taken to remove all substances from the eye by using standard irrigation/ aspiration techniques. Also be aware that dyes used intraoperatively (e.g. trypan blue) may cause staining of the IOL. - Salt precipitation in/on the lens may occur in very rare cases when using exogenous material such as, but not limited to, add-on lens, air or gas during corneal surgery or vitrectomy. The mechanism and the incidence are to date not clear.
• CW025

  EUDAMED did not publish a description for this code.

Primary placement in Germany; available across 1 country total.

Trade name

not provided

UDI-DI code

04049154009039

Basic UDI-DI

04049154_PC_M2_H3_O2_C7

Reference / catalog number

00083100

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.

• P030102090202IOLs, APHAKIC, MONOFOCAL, ASPHERIC, HYDROPHILIC ACRYLIC

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