OCT500

ESSILOR INTERNATIONAL · Model OCT2JT · UDI-DI 03615020000489

OBO HKI Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

3D Optical Coherence Tomography OCT500 is a non-contact, high-resolution tomographic and biomicroscopic imaging device. It is indicated for in-vivo viewing, axial cross-sectional and three dimensional imaging, and measurement of posterior ocular structures, including the retina, retinal nerve fiber layer, ganglion cell plus inner plexiform layer, ganglion cell complex, macula, optic nerve head. It is also indicated for in-vivo viewing, axial cross-sectional and three dimensional imaging of anterior ocular structures, including the cornea. The instrument is intended for use as a diagnostic device to aid in the detection and management of ocular diseases including, but not limited to, macular holes, cystoid macular edema, diabetic retinopathy, agerelated macular degeneration, and glaucoma.

Recalls

Date	Firm	Reason
2022-01-14	Carl Zeiss Meditec, Inc.	Optic nerve head angiography scan to be turned off due to its distribution without pre-market clearance.
2021-11-03	Haag-Streit USA Inc	Malfunction of the automatic laser beam shut-off, the OCT unit might not recognize whether the laser beam is safely switched off
2021-07-08	Carl Zeiss Meditec, Inc.	Due to failure to acquire pre-market clearance for its high resolution tomographic/biomicroscope imaging device (Model 6000) prior to commercializing the device.
2019-07-03	Heidelberg Engineering GmbH	Error in the default configuration which could lead to the incorrect display of patient master data.
2018-10-16	Carl Zeiss Meditec, Inc.	Under certain fault conditions, the existing design may expose the operator to a hazardous voltage when contacting the metal enclosure (including mounting screws) around the up/dow
2017-12-08	Heidelberg Engineering	FDA notified Heidelberg Engineering that a 510(k) clearance is needed for the SPECTRALIS Widefield OCT feature, and, on November 27, 2017, Heidelberg Engineering submitted a new 51
2012-09-07	Optovue Inc.	Devices labeled for an intended use not included in the existing 510(k) or PMA. Specifically, "The Retina" poster provided with the systems, and the book "RETINAL OCT Analysis and
2012-02-21	Optovue Inc.	A few doctors in the US were inadvertently sent the Cornea Power software version kit for international users instead of the domestic version.
2011-03-10	Carl Zeiss Meditec Inc	A software defect exists in versions 5.0.0 and 5.1.0 where when following a specific workflow, exam data may be saved under the name of the first patient
2011-03-10	Carl Zeiss Meditec Inc	A software defect exists in versions 5.0.0 and 5.1.0 where when following a specific workflow, exam data may be saved under the name of the first patient

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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.