CIRRUS photo
Carl Zeiss Meditec AG · Model CIRRUS photo 600 · UDI-DI 04049471096019
Description
The CIRRUS photo is a non-contact, high-resolution tomographic and biomicroscopic imaging device that incorporates a digital camera which is suitable for photographing, displaying and storing the data of the retina and surrounding parts of the eye to be examined under mydriatic and nonmydriatic conditions. These photographs support the diagnosis and subsequent observation of eye diseases which can be visually monitored and photographically documented. The CIRRUS photo is indicated for in-vivo viewing, axial cross sectional, and three-dimensional imaging and measurement of anterior and posterior ocular structures, including cornea, retina, retinal nerve fiber layer, macula and optic disc. It also includes a Retinal Nerve Fiber Layer (RNFL), Optic Nerve Head (ONH), and Macular Normative Database which is a quantitative tool for the comparison of retinal nerve fiber layer, optic nerve head, and the macula in the human retina to a database of known normal subjects. The CIRRUS photo 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, age-related macular degeneration and glaucoma.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-12-20 | Merge Healthcare, Inc. | Certain configurations of Merge Eye Station hardware may result in electrical output that exceeds the allowable limits for medical devices. Leakage current was found to exceed allo |
| 2017-07-27 | Optovue, Inc. | FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting). |
| 2016-12-09 | Merge Healthcare, Inc. | This recall has been initiated due to an issue related to the potential accidental deletion of record(s) by an Eye Station user. |
| 2016-12-09 | Merge Healthcare, Inc. | Merge received reports of Merge Eye Station being unable to capture images of the eye as expected per the intended use of the product. Merge is recalling product from the field to |
| 2014-06-16 | Nidek Inc | Image taken by AFC-330 has a white spot which may affect diagnosis or evaluation of image. |
| 2014-03-07 | Clarity Medical Systems Inc | One lot of Halogen lamps have the potential to fail sooner than the expected life of the lamp which could result in damage limited to the internal electrical components inside the |
| 2014-01-24 | Clarity Medical Systems Inc | Software anomaly for RetCam 3, RetCam Shuttle and RetCam Portable with software versions 6.0.x, 6.1. x and 6.2x where the patients age is calculated incorrectly. |
| 2013-08-01 | Nidek Inc | Under certain circumstances, the Left eye image may be saved as the Right eye image. |
| 2012-02-02 | Clarity Medical Systems Inc | Still images extracted from video recordings may be mislabeled as to right and left eye. |
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