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FDA approves Haag-Streit optical biometer

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MASON, Ohio — Haag-Streit USA received U.S. Food and Drug Administration approval for its LENSTAR LS 900 optical biometer, the company announced.

The company was granted 510(K) clearance to market the device, according to Liz Vogel, a company spokesperson. A distributor will be named later, after a contract is awarded, Ms. Vogel said.

According to a press release, the LENSTAR LS 900 is the first optical biometer with optical low-coherence reflectometry (OLCR), and it enables the rapid measurement of nine parameters in a single scan: pachymetry, keratometry, anterior chamber depth, lens thickness, axial length, white-to-white distance, pupillometry, eccentricity of the visual axis and retinal thickness.

"This speed is much more convenient and comfortable for patients, and LENSTAR's quick scan capabilities significantly improve patient cooperation and diagnostic integrity, even among techs with varying levels of expertise," the release said.

OLCR technology enables complete laser interferometric assessment.

"LENSTAR automatically detects loss of fixation and pauses until fixation is resumed. All measurements are captured on the visual axis, assuring precise measurements and accurate repeatability," the release said.

The device interfaces with an external personal computer and may be networked to electronic medical record systems. It is ideal for practices that offer premium IOLs and post-refractive IOL implantation surgery, the company said.