Intraocular Lens Analytical Services

  • What is an Intraocular Lens?

    Intraocular lenses (IOL) are surgically implanted medical devices which are most often used to treat cataracts, nearsightedness and/or astigmatism. IOLs incorporate a variety of lens geometries and materials for the purpose of optimizing vision correction. Some of the materials used include PMMA, acrylic and silicone based polymers. Next generation IOLs seek to enhance overall vision quality by addressing multiple vision problems in one device, or enhancing devices for easier and safer surgeries. These new devices will incorporate novel polymer materials which will require analytical investigations such as those listed under ISO 11979-5 to ensure they are safe for implantation into humans.

  • What is an Intraocular Lens?
Intraocular Lens Analytical Services at EKG Labs

EKG Labs provides analytical services to support companies developing intraocular lenses according to the guidance set forth under ISO 11979-5 regarding biocompatibility. Our team has experience working with the various polymeric materials used in IOLs and preparing the relevant data for regulatory submissions. This means EKG Labs is an ideal analytical service partner for companies developing novel intraocular devices and wish to understand the biocompatibility of their device.

ISO 11979-5 Guidance and Biocompatibility Testing at EKG Labs

The following series of tests is used to evaluate the physicochemical properties of IOLs that are relevant to biocompatibility:

  • Exhaustive Extraction: EKG Labs performs exhaustive extraction on intraocular lens material to detect and quantify extractable additives and other potential leachables under exhaustive extraction conditions. The exhaustive extraction is typically performed on multiple lots using multiple solvents. The extracts are then traditionally analyzed for volatiles, semi-volatiles and non-volatiles using techniques such as Gas Chromatography with Mass Spectrometry Detection (GC/MS) and Liquid Chromatography with Mass Spectrometry Detection (LC/MS).
  • Leachables: EKG Labs performs leachables testing on ocular implants to detect and quantify extractable additives and other potential leachables under physiological conditions. The leachable study is typically performed on multiple lots in multiple solvents. The extracts are then traditionally analyzed for volatiles, semi-volatiles and non-volatiles using techniques such as UV/Vis, Gas Chromatography with Mass Spectrometry Detection (GC/MS) and Liquid Chromatography with Mass Spectrometry Detection (LC/MS). The extracted samples are also analyzed for spectral transmission using UV/Vis analysis.
  • Hydrolytic Stability: EKG Labs performs hydrolytic stability testing on ocular implant samples to determine the stability of the IOL material in an aqueous environment. This is done through the detection and quantification of possible degradation products from hydrolysis detected through changes in physical appearance, optical properties and chromatographic characteristics. The hydrolytic stability is typically performed in duplicate, on multiple lots, using an aqueous medium. The extracts are then traditionally analyzed for volatiles, semi-volatiles and non-volatiles using techniques such as UV/Vis, Gas Chromatography with Mass Spectrometry Detection (GC/MS) and Liquid Chromatography with Mass Spectrometry Detection (LC/MS). The extracted IOL samples are also analyzed for spectral transmission using UV/Vis analysis, dioptric power and microscopy.
  • Photostability: EKG Labs performs photostability testing on ocular implant samples to determine the photostability of the IOL materials if irradiated in the wavelength range of 300 nm to 400 nm. The photostability study is typically performed on multiple lots which are submerged in physiological saline. After exposure, the medium is analyzed for volatiles, semi-volatiles and non-volatiles using techniques such as UV/Vis, Gas Chromatography with Mass Spectrometry Detection (GC/MS) and Liquid Chromatography with Mass Spectrometry Detection (LC/MS). The exposed IOL samples are also analyzed for spectral transmission using UV/Vis analysis.
  • Insoluble Inorganics: EKG Labs analyzes the intraocular lens material for residual insoluble inorganics on and in the lens using ICP-MS. Typically two analyses are performed, one on the entire intraocular lens and one from a wash from the surface of the lens.

Additional information regarding how we can support intraocular lens or ISO 11979-5 guidance testing can be found below: