However, the lens got stalled in the FDA approval process for three years, and eventually AMO discontinued it.THE STALLED Sapphire Autofocal (Elenza, Inc.) is billed as the first “electro-active” accommodating IOL.Nu Lens (Nu Lens Ltd.) is a single-optic, mechanical accommodating IOL designed to provide up to 10 D of accommodation.Nu Lens works like a piston: eye muscles push against a silicone gel lens, which changes shape to provide focus at different distances. The (Akkolens) is a dual-optic, mechanical accommodating lens designed for placement in the sulcus, as sulcus placement may be less affected by fibrosis than placement in the capsular bag. (Very similar in design, the FDA allows Crystalens to be called “accommodating” but only allows Trulign to be described as offering “a broader range of vision.”) Both are mechanical IOLs because accommodation is powered by action of the ciliary muscle as opposed to, for example, electricity.In clinical studies, Crystalens and Trulign have been shown to provide about 1 diopter of accommodation.Multifocal patients often complain of seeing glare and halos, especially at night, in the first few months after surgery.As a result, considerable time and money are being invested in the development of IOLs that reduce or eliminate the problems of current multifocals.
It received a CE mark in 2006, but is not yet FDA-approved.
IOL developers continue to investigate new accommodating designs in hopes of gaining enough accommodation to provide sharp vision at all distances.
A Review of the Current Pipeline THE APPROVED Crystalens® and Trulign® Toric (both by Bausch Lomb) are currently the only FDA-approved IOLs that can be described as accommodating.
The FDA approved the original version of Crystalens in 2003, at which time it was developed and marketed by a startup company called eyeonics.
Bausch Lomb acquired Crystalens in early 2008; and in June of that year, the FDA approved a “high-definition” version of Crystalens, which incorporates an optic designed for better near vision.