An Intraocular Lens (IOL) is a medical implantable lens placed inside the eye, typically to replace the eye’s natural lens after cataract removal or, for some products, to correct refractive errors such as myopia, hyperopia, or astigmatism. IOLs usually consist of a clear optic with haptics to center and stabilize the lens in the appropriate anatomic position.

Intended Use of Intraocular Lenses (IOLs)

Intraocular lenses are intended to be implanted in the eye to replace or supplement the natural crystalline lens, restore or provide refractive correction, and improve visual acuity following cataract removal or to correct refractive errors. Patients can expect improved vision at distances depending on the lens design.

To replace the natural crystalline lens removed during cataract surgery and provide refractive correction.

Device Description:
A single-optic implantable lens designed to be surgically placed in the posterior chamber of the eye after the native lens is removed. Usually made of biocompatible materials (acrylic, silicone, PMMA) with haptics to stabilize the optic.

Key Features:

• Monofocal optics – focuses light at one focal point (distance or near)
• Passive implant
• Permanent implant

Multifocal Intraocular Lens

Intended Use:
To replace the natural lens after cataract removal and provide multiple focal points to improve vision at near, intermediate, and distance without spectacles.

Device Description:

An implantable lens with optical zones or diffractive structures that provide multiple focus ranges. Typically uses optical designs to split incoming light to different focal points.

Toric Intraocular Lens

Intended Use:

To replace the natural lens after cataract surgery and correct corneal astigmatism by orienting the lens along a specific axis.

Device Description:
An implantable lens with a toric optical power in addition to spherical correction. The toric axis must be aligned with the patient’s astigmatic axis to correct irregular refractive power.

Accommodative Intraocular Lens

Intended Use:
To replace the natural lens after cataract surgery and allow some dynamic focusing ability to improve near and distance vision through movement of the lens implant.

Device Description:

A lens designed to change its effective optical power by shifting position or shape within the eye, mimicking accommodation of the natural crystalline lens.

Iris Reconstruction Intraocular Lens

Intended Use:
To replace or reconstruct the iris/lens complex in eyes with deficient or absent iris and crystalline lens.

Device Description:
Specialty IOLs designed with iris-support features or anatomical reconstruction designs for complex clinical situations.

Extended Depth of Focus (EDOF) Intraocular Lens

Intended Use:

To replace the natural lens after cataract surgery and provide a continuous range of vision (extended depth of focus) from distance to intermediate.

Device Description:
An IOL with optical design that elongates the focus region to minimize visual disturbances while enhancing intermediate vision.

Light Adjustable Lens (LAL) and Light Delivery Device (LDD)

Intended Use

The light adjustable lens (LAL) is an intraocular lens intended to be implanted in the eye to replace the natural crystalline lens removed during cataract surgery and to provide refractive correction. After implantation, the lens optical power can be adjusted post-operatively using a specialized ultraviolet (UV) light delivery device to refine refractive outcomes for improved visual acuity.

Device Description

The PZK Light Adjustable Lens (LAL) system consists of two primary components:

Implantable Light Adjustable Lens

• A sterile, single-use intraocular lens made of a photosensitive material that can have its optical power adjusted after surgery when exposed to controlled doses of UV light.
• Typically placed in the posterior chamber like other IOLs.

Light Delivery Device (LDD)

• A specialized ophthalmic device that delivers controlled UV light to the implanted LAL to customize optical power (focus) after implantation, helping optimize visual outcomes such as reduced residual refractive error.

Key Features that Differentiate PZK from Other IOLs:

• Post-implant adjustability of refractive power via UV light exposure.
• Requires both the implantable lens and the light delivery system to achieve the intended clinical effect.
• Enables personalized refractive optimization after the eye has healed from surgery — a capability not present in standard monofocal, multifocal, toric, EDOF, or accommodative IOLs.

Phakic Toric Intraocular Lens

Intended Use:
To correct refractive errors (including astigmatism) in eyes that retain the natural crystalline lens (phakic eyes) without removing the natural lens.

Device Description:
An implantable lens is placed without removing the natural lens, typically in the anterior chamber or sulcus, to change refractive power.

Performance Testing (Analytical) for Intraocular Lens:

• Optical performance
• Power accuracy
• Wavefront analysis
• Manufacturing controls
• Material characterization
• Mechanical and Delivery Testing
• Injector and delivery system performance
• Handling characteristics
• Lens unfolding and positioning stability
• Biocompatibility (ISO 10993 Series)
• Sterilization & Shelf Life
• Animal Studies

Clinical Testing:

Required