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Remidio
REMIDIO INNOVATIVE SOLUTIONS PRIVATE LIMITED · Model PSL - D20 · UDI-DI 08906096520045
10
510(k) clearances
215
Adverse events
8
Recalls
56
Facilities
Description
Remidio Portable Slit Lamp (PSL-D20) is a handheld digital device for anterior segment screening & diagnosis of the human eye. High-resolution images obtained with advanced optics and using iPhone’s latest technology. User-friendly iOS enhances the imaging technology and the Remidio patient management application enable the user to view, save, archive, edit and retrieve the captured Anterior Images using a built im-age archival database.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-04-15 | Haag-Streit USA Inc | Examination data and patient name may be mixed up when printing or generating a pdf with the interface at Pacific Coast and Laser Institute (PCLI). |
| 2020-12-07 | Carl Zeiss Meditec AG | When using software 1.90.2.09 or 1.90.8.06 and using modality worklist functionality for patient data transfer, the selection of the patient in the patient list may not match the p |
| 2018-06-25 | Carl Zeiss Meditec AG | Calibration setting was incorrectly entered during manufacturing causing the optical coherence tomography (OCT) to obtain the incorrect two-dimensional images of ocular structures |
| 2016-07-01 | Nidek Inc | Nidek Inc. received information from our manufacturer NIDEK CO. Japan that the shown axial lengths were much shorter at AL-Scan measurement. |
| 2015-10-27 | Carl Zeiss Meditec AG | IOL Master software versions 7.5 and 7.7 calculation printouts and exported reports can contain the wrong IOL power data. |
| 2015-10-27 | Carl Zeiss Meditec AG | IOL Master software versions 7.5 and 7.7 calculation printouts and exported reports can contain the wrong IOL power data. |
| 2013-10-23 | Carl Zeiss Meditec, Inc. | The user database delivered for download contained an erroneous value. Specifically the "aO" constant of the lens AMO Sensar AR40E is listed as "0.0" in the internal lens database |
| 2013-10-23 | Carl Zeiss Meditec, Inc. | The user database delivered for download contained an erroneous value. Specifically the "aO" constant of the lens AMO Sensar AR40E is listed as "0.0" in the internal lens database |
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Get your free API keyRead the docsData 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.