ESSILOR RETINA 400
ESSILOR INTERNATIONAL · Model RETINA 400 · UDI-DI 03615020000267
Description
Retina 400 is an electromedical system that allows for digitally retrieving, acquiring and processing of a retinal image, for use in ophthalmological diagnosis by medical specialists, and other uses inherent to the professional activity of other operators, optometrists and opticians, to the extent permitted by the laws and regulations for the exercise of their profession. An absolute new entry in the field for retinal imaging, the instrument allows for a direct, "live" monitoring on the computer screen, and capturing also in cases where the pupil diameter is extremely narrow. The instrument, with manual acquisition and electronically guided control, guarantees high precision and repeatability of the measurements.
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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