Eyenable®

Trade name

Eyenable®

UDI-DI code

06970918380041

Basic UDI-DI

B-06970918380041

Reference / catalog number

PA60AS1

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

Eyenable® Hydrophobic Acrylic Monofocal Intraocular Lens (PA60AS1) is a foldable single-piece posterior chamber intraocular lens (IOL) with hydrophobic acrylic material and a high refractive index. It is designed to replace the human crystalline lens for the visual correction of aphakia in adult patients after cataract removal. The lens features an aspheric optic with negative spherical aberration, effectively minimizing total spherical aberration in the pseudophakia eye. Additionally, it includes supporting haptics that ensure proper positioning of the IOL optic within the capsule.

Additional information URL

https://www.eyedeal.com/en/%202017/10/15/instructions-for-use/

Clinical sizes

No clinical sizes registered for this device.

European Medical Device Nomenclature — the EU product classification assigned to this device.

• P030102090201IOLs, APHAKIC, MONOFOCAL, ASPHERIC, HYDROPHOBIC ACRYLIC

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