500069

Organization name

Pharmpur GmbH

SRN

DE-MF-000008337

Manufacturer status

Active

7 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.
• CW032

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

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

  Injection of excessive amounts of ophthafutur hpmc 2 % may increase intraocular pressure (IOP) temporarily. An excessive IOP may also be caused by a pre-existing glaucoma condition, by reduced outflow, and by operative procedures and their aftereffects. Because these factors vary from case to case and are difficult to predict, the following precautions are recommended: Do not overfill the eye with ophthafutur hpmc 2 %. At the end of surgery, all remaining ophthafutur hpmc 2 % should be removed by irrigation and/or aspiration. Carefully monitor the IOP, especially during the immediate post-operative period. In case that a significant increase of IOP is observed, treat appropriately. Avoid the injection of an air bubble at the end of the surgery.
• CW999

  With topical use of ophthafutur hpmc 2 %, e.g. in the gonioscopy, the vision can temporarily slightly decrease due to the occurrence of streaks. Make sure that ophthafutur hpmc 2 % does not dry.

Primary placement in Germany; available across 32 countries total.

Trade name

not provided

UDI-DI code

04260260050535

Basic UDI-DI

B-04260260050535

Reference / catalog number

500069

Issuing entity

GS1

Risk category

Class IIb

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

Viscoelastic

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Q02030399OPHTHALMOLOGY, VISCOELASTIC FLUIDS - OTHER

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