Summary
Rayner Intraocular Lenses Limited, the world’s original manufacturer of IOLs, has announced that it has received CE Mark approval for the Sulcoflex® Multifocal Toric IOL.
This CE Mark approval completes the product family of Sulcoflex® lenses – aspheric, toric, multifocal and multifocal toric – allowing Rayner to expand its range of IOLs offered in the European Union. The Company expects to release the product into the market during Q1, 2012.
About Sulcoflex® Supplementary IOLs
Sulcoflex® supplementary IOLs are designed to be implanted in the ciliary sulcus, as an addition to a primary lens already present in the capsular bag. Indications for Sulcoflex® include; the correction of residual ametropia, presbyopia or astigmatism in existing pseudophakes, the enhancement of refractive results after LASIK, PRK, PRELEX or RLE and extreme myopia or hyperopia. Sulcoflex® may also be an effective solution for cataract patients with a dynamic change of refraction.
There have also been a small number of cases where biometry readings have been difficult to assess when a primary lens is implanted and in these cases, Sulcoflex® can adjust the refraction where correct lens power is uncertain. The optic and unique undulating haptics of Sulcoflex® have been designed to maintain a distance between the supplementary lens and its primary lens neighbour, thus avoiding the problems of interlenticular opacification associated with the conventional “piggyback” technique. The Sulcoflex® is also vaulted posteriorly to avoid contact with the iris and thus it avoids “iris chafe” and pigment dispersion. Rayacryl®, the hydrophilic acrylic material of Sulcoflex®, ensures a high degree of biocompatibility with the uveal tissues in the sulcus.
Sulcoflex® IOLs are designed to avoid the trauma, or increased surgical risk, of an IOL exchange and can be comparatively easily removed from the sulcus, should there be a need to reverse the procedure or exchange the lens at a later date.
Source: Rayner
published: December 5, 2011 in: Approval/Clearance, Ophthalmics, Regulatory