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Automated Perimeter

OPTOPOL TECHNOLOGY SP Z O O · Model PTS 925 · UDI-DI 05903293141144

HPT Prescription
10
510(k) clearances
3
Adverse events
1
Recalls
67
Facilities

Description

The PTS 925 automated perimeter is a diagnostic instrument intended for visual field testing. The device is used for early detection of glaucoma, cataract, neurological defects, diplopia, and retinal diseases, including macular degeneration, retinitis pigmentosa, or scintillating scotomas.

Recalls

DateFirmReason
2012-08-17Haag-Streit USA IncThe firm recalled the device after learning of a possible deviation in the stimulus luminance of the Perimeter OCTOPUS 101.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.