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OPTICAL BIOMETER

SANTEC CORPORATION · Model ARGOS ver1.5 · UDI-DI 04573344510024

MXKHJO Prescription
1
510(k) clearances
12
Adverse events
7
Recalls
18
Facilities

Description

ARGOS is a non-invasive, non-contact biometer based on swept-source optical coherencetomography (SS-OCT). The device is intended to acquire ocular measurements as well asperform calculations to determine the appropriate intraocular lens (IOL) power and typefor implantation during intraocular lens placement. ARGOS measures the following 9parameters: Axial Length, Corneal Thickness, Anterior Chamber Depth, Lens Thickness,K-values (Radii of flattest and steepest meridians), Astigmatism, White-to-white(corneal diameter) and Pupil Size. The Reference Image functionality is intended for useas a preoperative and postoperative image capture tool.It is intended for use by ophthalmologists, physicians, and other eye-care professionalsand may only be used under the supervision of a physician.

Recalls

DateFirmReason
2023-08-08Oculus Optikgeraete GMBHTheir is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements.
2023-08-08Oculus Optikgeraete GMBHTheir is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements.
2023-08-08Oculus Optikgeraete GMBHTheir is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements.
2022-07-08Oculus Optikgeraete GMBHDue to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning toric IOLs
2022-07-08Oculus Optikgeraete GMBHDue to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning toric IOLs
2022-07-08Oculus Optikgeraete GMBHDue to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning toric IOLs
2017-11-21Oculus Optikgeraete GMBHThe device software versions have an anomaly which may produce an erroneous marking for the quality specification value

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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.