Tomey Optical Biometer OA-2000 (OA-2000)

The Tomey OA-2000 is a non-invasive, non-contact optical biometer that measures ocular parameters (axial length, corneal thickness, anterior chamber depth, and lens thickness) to assist physicians in determining the appropriate intraocular lens power for cataract surgery. It uses Fourier-domain optical coherence biometry technology and includes an internal IOL power calculation database with multiple formula options.

The OA-2000 uses Fourier-domain optical biometry versus the predicate's time-domain approach, both based on low-coherence interferometry. It employs placido ring technology for corneal curvature measurement versus the predicate's keratometry dots. Measurement ranges are slightly broader for axial length (14–33.5 mm vs. 14–32 mm) and corneal curvature radius (5.0–11 mm vs. 5–10.5 mm), with minor differences in other parameters that do not affect safety or effectiveness.

ISO 10993-1:2018 (biocompatibility), IEC 60601-1 Ed.3.2 (electrical safety), IEC 60601-1-2 Ed.4.1 (electromagnetic compatibility), ANSI Z80.36:2021 (laser safety), and ISO 14971:2019 (risk assessment). Software documentation followed FDA guidance, and cybersecurity was assessed per FDA guidance for management of cybersecurity in medical devices.

The OA-2000 has the same intended use as the predicate LENSTAR LS900 and measures the same core parameters with equivalent accuracy and performance. Although the OA-2000 uses Fourier-domain technology instead of time-domain, both are applications of low-coherence interferometry that do not raise new safety or effectiveness questions. Clinical testing with 224 subjects demonstrated excellent agreement and precision between devices across normal, cataract, and special eye populations, with no adverse events reported.